Longevity Industry Jobs

We are currently seeking an energetic and experienced individual with viral vector and/or cell therapy quality control background to join our Quality Control Development (QC) team. The successful candidate will contribute to the advancement of Adicet’s product pipeline by managing external sample testing, assisting in-house sample analysis, and other assigned tasks. You will also be expected to independently organize, analyze, and present results and conclusions.

The individual will work as part of the QC team in collaboration with Manufacturing, Process Development, and Research teams, as well as external collaborators to advance diverse projects while adhering to communicated timelines.

Key Responsibilities

• Receive and manage samples: The QC Specialist will be responsible for receiving and tracking all samples, ensuring that they are properly labeled, accounted for, and stored.
• Coordinate sample shipment and testing: The QC Specialist will coordinate the shipment of samples to internal and external testing facilities and ensure that all necessary documentation is in place.
• Receive, review, archive, and trend test results from external testing laboratories: The QC Specialist will receive and review the test reports to ensure that they meet quality standards. The QC Specialist will maintain a complete and organized archive of all test results, including trending analysis and documentation as needed.
• Support in-house QC testing: The QC Specialist may assist in-house quality control testing as needed.
• Review test records and other documents: The QC Specialist will review test records and other related documents to ensure accuracy and compliance.
• Assist investigations: The QC Specialist will assist non-conformance investigations and draft investigation reports.
• Coordination with Quality Assurance: The QC specialist will assist in the compilation of data packages to provide to the Quality Assurance team to facilitate release of raw materials or finished products.

Qualifications

• BS or MS in biological sciences or a related field is required.
• 3+ years of relevant experience in Pharmaceutical or Biotechnology industry is required.
• Experience in cGMP procedures is strongly preferred.
• Experience in at least two areas of the followings is required: cell culture, cell-based assays, immunoassays, and flow cytometry.
• Experience with cell therapy QC methods is highly desired.
• Ability to analyze and interpret complex data.
• Excellent communication and interpersonal skills.
• Ability to work independently, multitask, and meet deadlines in a fast-paced environment.
• Highly motivated, organized, detail oriented, and disciplined record keeping.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $96,000.00 - $134,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

In this role you will partner with the HR leadership to inform the HR Operations strategic direction for Adicet. You will be responsible for the HRIS design, implementation, integration, and administration, as well as for successful integration between the HRIS and other HR & Finance systems including: applicant tracking, benefits enrollment systems, payroll, and all data feeds to various partners and external systems.

You will manage our compensation programs to ensure alignment with company mission, values, goals and competitive practices. You will ensure HR-related policies, programs and systems are consistently administered in compliance with company and quality policies.

This role requires you to be a strategic thinker to enable the organization as it scales, an advisor to employees as they navigate important topics (such as employee benefits and compensation) and a proven collaborator with key functional partners.

Key Responsibilities

HR Operations

• Design and develop a HRIS roadmap and implement new systems and process improvements with a focus on usability for end-users and process/cost efficiencies.
• Provide management oversight of the day-to-day operations related to HRIS systems and technology.
• Create, coordinate with legal and other stakeholders, review, edit and implement HR policies, ensuring functional experts are appropriately engaged and contributing timely content. Oversees review and publishing of final policies, gain approval and is responsible for ongoing policy review.
• Ensure awareness of and compliance with state and federal employment regulations; monitors legislative matters impacting human resources and alerts leadership as and when needed.
• Ensure appropriate procedures are in place for compliance as the company scales (e.g. I-9, SOX, etc.).
• Monitor employee classifications to ensure compliance with Fair Labor Standards Act (FLSA) guidelines.
• Serve as the HRIS data trustee, implementing and maintaining proper data integrity procedures, audits and system/process controls.
• Ensure the accuracy and quality of HR information as used by employees, management, third party administrators, auditors, and regulatory authorities.

Compensation

• Make strategic recommendations, implement, and administer total reward plans (benefits programs, direct compensation, annual incentive, and long-term incentive programs) to attract, retain, and motivate talent.
• Establish the benefits plan strategy and design; ensure relevant partners are in place and ensure plan is communicated effectively with executives and employees on an annual basis.
• Develop compensation recommendations to maintain internal equity and external competitiveness and to ensure compliance with all regulatory requirements.
• Identify, complete, and analyze compensation surveys annually.
• Create and implement the annual compensation review plan, timeline, tools and resources to support the organization with cash and incentive compensation decisions each year.
• Ensure compliance related to compensation regulations, including the Fair Labor Standards Act (FLSA), Equal Pay Act, American with Disabilities Act (ADA), Lilly Ledbetter Act, etc.

Job Requirements

• Bachelor’s Degree Business or related field and at least eight years of progressively responsible experience in HR management, HRIS and compensation & benefits administration, or Master’s Degree and at least five years similar experience.
• Solutions driven team player with the ability to coach those that do not report to you .
• Proven ability to lead a variety of projects including gap assessment, analysis, solution design and implementation.
• Experience as an organizational change leader with ability to manage communications, training, etc. as processes, procedures, systems and technology changes are made.
• In depth knowledge of US regulatory compliance and controls; demonstrated experience ensuring employer compliance with federal, state and local laws and regulations related to compensation and employment practices through proper operating and governance procedures.
• Outstanding analytical, mathematical, and problem-solving skills
• Excellent oral and written communication skills; experience interacting effectively with executives.
• Ability to effectively delegate, coach and develop others.
• Ability to handle confidential information with extreme discretion.
• Advanced Microsoft Office skills, particularly Excel.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $193,000.00 - $268,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet Bio is developing a next generation manufacturing process to advance our platform of “off-the-shelf” immune cell products. We are currently seeking individuals for our viral vector group as we advance our production platforms. The position offers a chance to be part of a highly motivated team, applying the latest cell culture and bioprocessing practices to facilitate development of our proprietary cell therapies.

We are currently seeking an energetic and experienced individual with a strong background in mammalian cell bioreactor development to join our upstream viral vector team. The successful candidate will contribute to the advancement of Adicet’s production platform by developing, characterizing, and optimizing vector production procedures designed to support both research and manufacturing pipelines.

The individual will serve as a program specialist reporting to the Upstream Vector team leader. Working in collaboration with other junior scientists, as well as the Downstream and Analytical vector teams, this individual will be responsible for translation of research processes into scalable platforms for generation of viral vectors using suspension-based bioreactor cultures. This individual will also work with other Technical Operations teams, and external groups, to meet project timelines and deliver a consistent and robust viral vector production program.

Additional Responsibilities

• Design experimental approaches to optimize cell growth and viral vector yield from mammalian suspension cultures.
• Set-up and operation of benchtop and large scale (> 50L) bioreactors designed to meet experimental goals designed to expand and improve upstream culturing capabilities.
• Serve as an SME for bioreactor operation, applications, and data interpretation when communicating with external groups.
• Drafting and editing of standard operating procedures, sampling plans, technical documents, and batch records for developmental and tech transfer purposes.
• Successfully execute and document laboratory procedures and experiments with great attention to detail.

Upstream Viral Vector Development - Qualifications

• Education, Experience, and Skills Requirements
• Candidate with a background in biology, biomedical engineering, biochemistry, cell & molecular biology, or related life science field is required. Master’s degree or bachelor’s degree with 2+ years or 4+ years post-graduate experience, respectively.
• Considerable direct experience with mammalian cell culture and parameter optimization utilizing suspension-based bioreactor systems is required.
• Familiarity with current principles and technical platforms for monitoring cell growth profile and metabolic profile, etc is expected.
• Qualified candidates should be detail oriented with an ability to multi-task and meet deadlines in a fast-paced environment.
• Must have excellent verbal and written communication skills.
• Must be proficient with MS Office and other commonly used software and technology programs
• Other qualifications
• Candidates having prior experience in viral vector production applications will be given strongest preference.
• Experience in working in a BSL-2 environment is strongly desired.
• Hands-on experience with various liquid handling or perfusion filtration systems is strongly desired.
• Experience with media formulation optimization is desirable.
• Previous experience conducting technology transfers to external CMOs or adapting client-derived upstream process as a part of a CMO is desirable.
• Candidates who have experience with experimental design programs (JMP, Design-Expert, etc.) will be given preference.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $100,000.00 - $138,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

PROCESS DEVELOPMENT ENGINEER 4

Responsibilities

• Perform studies to scale-up CAR T manufacturing processes based on the gamma delta T cell platform using the Xuri and Sartorius bioreactors.
• Execute cell culture based experiments utilizing novel technologies to improve platform processes such as automation and non-viral transduction strategies
• Create improvements to platform process for activation, transduction, and expansion unit operations
• Perform multi-color flow cytometry acquisition and analysis
• Tracking and ordering requisite consumables for PD and MS&T subteams
• Accurately compile data in electronic notebook entries and aggregate data files

Qualifications

• BS/MS/PhD in Biochemical Engineering, Chemical Engineering, Science or Biotechnology.
• BS with 5+ years or MS with 3+ years’ experience in industry setting or PhD with relevant cell therapy experience
• A strong background in cell therapy or CAR T products required
• Experience in aseptic technique, cell culture, and retroviral or lentiviral transductions
• Expertise with flow cytometry for T cells
• Expertise with Microsoft Office suite, JMP, Prism, FlowJo, Benchling (or other electronic lab notebook software)
• Experience with GMP processing and/or tech transfer related activities a plus
• Assist in conducting analysis and reporting results, and interpretation of data.
• Possesses good verbal and written communication skills
• Ability to operate in a fast paced, industrial environment

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $102,400 - $166,000 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

We are seeking a highly motivated and experienced individual with a strong background in cell process development/manufacturing. The Manufacturing Associate 2 will report to the Director of Manufacturing. In this role you will support the daily manufacturing operations of allogeneic CAR T cell therapies, assist with troubleshooting complex and non-routine equipment events, initiate and support deviations, and author SOPs. You will implement Good Manufacturing Practices and best practices to streamline manufacturing operations.

You will demonstrate expertise and breadth of knowledge in executing processes across a variety of production activities such as cell processing, aseptic behavior, monitoring equipment and processes, product sampling, and conducting routine sanitization tasks to maintain facility and equipment. You will read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify, and communicate non-routine events, and review more complex decisions with your direct supervisor.

Responsibilities

• Oversee and participate in the execution of cellular drug product manufacturing according to defined SOPs and manufacturing batch records within a cleanroom environment
• Operate and troubleshoot bioprocess equipment such as Sepax, LOVO, CliniMACS, functionally closed system bioreactors, and controlled rate freezers
• With Quality Assurance, supervisor, and Facilities, ensure preparedness for runs in terms of equipment readiness and operator training
• Troubleshoot OOE and OOT issues during routine manufacturing
• Manage, provide guidance, and support a team of manufacturing associates
• Collaborate with MS&T to refine MBRs and with SCM to generate supply orders to support BOM
• Must possess high degree of learning agility
• Support Quality Management system including but not limited to deviation investigations and risk assessments
• Understand and implement safety procedures.

Qualifications

• Bachelor’s degree in a biological science, engineering or related science discipline with 1-3 years of experience in a clinical processing and/or cell culture operations preferably in a GMP environment; or equivalent combination of education and experience.
• GMP experience in a cleanroom for cell therapy products required with previous experience in gown qualification, aseptic behavior, materials kitting, and aseptic flow of materials
• A strong background in cell therapy or CAR-T products preferred
• Working knowledge and understanding of GMP, GCP, GDP, and relevant FDA guidelines.
• Process-oriented with strong analytical skills for risk identification and management.
• Excellent verbal and written communication skills and can confidently communicate with all levels of staff in this collaborative work environment.
• Self-motivated and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Proficient in MS word, Excel, PowerPoint, Outlook and warehouse management software.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $75,000 - $127,000 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet bio is seeking a statistician who will be responsible of leading daily activities of clinical trials. The position will provide technical expertise and experience to conduct data analyses, recommendations to statistical designs for clinical trials of all phases. The position will work collaboratively across various functions in the planning, conduct and analyses of clinical trials.

The position will report to Vice president, Biometrics.

Responsibilities

• Author statistical analysis plan, TLF shells and table of contents for outputs to be generated.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Review ADaM specifications and verify key endpoints in TFLs.
• Review CRFs, CRF edit checks and CRF completion guidelines.
• Responsible for one or more studies with concurrent tasks and timelines.
• Aid in establishment of internal biostatistics processes and procedures.

Qualifications

• PhD degree in statistics or biostatistics
• 5+ year of statistical analysis experience in pharmaceutical or biotechnology industry (Including CRO)
• Familiar with SAS or R
• Demonstrate effective verbal and written communication skills and interpersonal skills.
• Proven ability of literature/scientific research and apply new methodology in clinical trials.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $180,000.00 - $266,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

The Manager, Regulatory Affairs prepares and submits regulatory filing documents and monitors and tracks information and requirement changes, with some interaction with regulatory agencies.

Key Responsibilities

• Assist Senior RA staff in the development of Regulatory Submissions for IND’s/DMFs/ARs/DSUR’s/OD/RMAT/BTD etc. and amendments/supplements.
• Coordinate, assemble and/or prepare for submission various materials to the FDA and ex-US Regulatory Authorities, such as IND’s/DMFs/ARs/DSUR’s/OD/RMAT/BTD etc. and amendments/supplements.
• Represent Adicet Bio and establish productive relationships with appropriate FDA personnel and ex-US Regulatory Authorities and to assure that the Company has an understanding of all applicable laws, regulations, and guidance.
• Assist in maintenance of the various company inhouse data bases, such as list of approved applications and tracking systems for regulatory submissions.
• Assist Senior RA staff in the development of Briefing Books for Agency meetings including pre-IND meetings, End of Phase meetings, RMAT submissions etc.
• Coordinate, assemble and/or prepare for submission various materials to the FDA and ex-US Regulatory Authorities, including Briefing Books for pre-IND submissions, End of Phase meeting etc.
• Work with Program Teams and Regulatory Department to define optimal RA strategy to take products through the development process to registration and commercialization.
• Support the preparation of regulatory submissions for investigational products through the development process to registration and commercialization, for ATMP’s.
• Support the development of regulatory strategies in the US and ex-US countries.
• Interact with cross-function teams to ensure optimal execution of the agreed regulatory strategy for investigational medicinal products.
• Work with CRO partner organizations to ensure timely, submission of applications for Clinical Trials in markets where Adicet Bio does not currently have a presence.
• Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams.
• Opportunity to develop publishing skills related to submission of electronic CTD compliant documentation.

Key Role-related Competencies

• Able to facilitate/impact and influence effective planning interactions and discussions.
• Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines.
• A good scientific background and understanding with the ability to acquire this knowledge in a short timeframe.

Core Competencies

• Knowledge of Statutory Framework and Guidance procedures followed by FDA/EMA.
• Understanding of product development.
• Strong verbal and written communication skills.
• Must have strong working knowledge of Microsoft Office and other PC-related applications.
• Must take initiative and have ability to work independently and as a team member, offer assistance wherever needed.
• Excellent oral and written English communication skills.
• Excellent planning and organisational skills with the ability to work simultaneously on a number of projects with tight timelines.
• Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
• Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
• Problem solving, strategic thinking skills with ability to impact and influence.
• Attention to detail with accuracy and quality.
• Ability to understand and effectively relate to external and internal customers.
• Business awareness and professionalism.

Education And / Or Experience Required

• Bachelor’s Degree in scientific discipline required, advanced degree preferred.
• Life Science degree and demonstrated relevant regulatory affairs experience.
• An understanding of regulatory requirements for the EU centralised procedure.
• Experience in supporting post-approval management of variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
• Experience in working with document management systems.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $126,000.00 - $174,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet Bio is developing a next generation manufacturing process to advance our platform of “off-the-shelf” immune cell products. We are currently seeking an individual for our Viral Vector group as we advance our production platforms. The position offers a chance to be part of a highly motivated team, applying the latest cell culture and bioprocessing practices to facilitate development of our proprietary cell therapies.

We are currently seeking an energetic and experienced Associate Director with a strong background in viral vector production to oversee process development, scale-up, and technology transfer for Adicet’s vector programs. The successful candidate will contribute to the advancement of Adicet’s production platform by developing, characterizing, and optimizing viral vector production procedures intended to support both research and manufacturing pipelines. The job title may be commensurate with experience and educational level.

The individual will serve as a program lead reporting to the Director of Viral Vector Development and will work in collaboration with the Downstream and Analytical Development leads, as well as other cross-functional teams, to develop a best-in-class vector manufacturing process. The successful candidate will guide development programs for vector generation, media/cell culture optimization for viral vector production platforms, and other aspects of viral vector production. This person will also work with other Technical Operations teams and external groups in order to align on goals, meet project timelines, and deliver a consistent and robust viral vector product.

Additional Job Responsibilities

• Independently lead, design, and help execute the upstream process development, and characterization of viral vectors in suspension culture platforms.
• Facilitate collaboration with Viral Vector Upstream and Downstream scientific staffs.
• Design and oversee optimization of critical parameters for retroviral vector production including development of cell culture condition and facilitate scale-up for manufacturing.
• Successfully execute and document laboratory procedures and experiments with great attention to detail.
• Serve as an SME for upstream viral vector applications, and data interpretation when communicating with external groups and providing technical support to internal/external manufacturing groups.
• Drafting and editing of standard operating procedures, sampling plans, technical documents, and batch records as a contributor to regulatory filings or for tech transfer purposes.
• Source and assess new equipment and technologies to expand and improve upstream culturing and viral vector production capabilities.
• Identify risks in vector production and develop mitigation plans in the upstream process to enable quick and robust decision making through efficient collaboration.
• Provide leadership and mentor junior and senior scientific staff.
• Contribute to budget and goal planning of the Upstream Viral Vector group in alignment with the Corporate goals.

Upstream Viral Vector Development - Qualifications

Education, Experience, and Skills Requirements

• Advanced degree with a background in biology, biomedical engineering, biochemistry, cell & molecular biology, or related life science field is required. Doctoral degree or master’s degree with 5+ years or 8+ years post-graduate experience, respectively. Candidates with previous experience in cell or gene therapy will be given preference.
• Considerable direct experience with viral vector production applications is required.
• Experience in working in a BSL-2 environment is required.
• Previous experience with suspension cultures using stirred-tank bioreactor systems (e.g. single-use bioreactors) to manufacture viral vectors (AAV and/or Lentiviral vector and/or Retroviral vector is required.
• Demonstrated competency and experience with viral vector upstream production, aseptic processing, process development, process qualification/validation and technology transfer for GMP production.
• Qualified candidates should be detail oriented with an ability to multi-task and meet deadlines in a fast-paced environment.
• Strong planning, capacity for managing multiple projects and excellent time management.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Previous experience managing and mentoring junior scientific staff.
• Must have excellent verbal, written communication and meeting management skills.
• Must be proficient with MS Office and other commonly used software and technology programs.

Other Qualifications

• Candidates having prior experience with upstream process optimization and/or media development will be given strongest preference.
• Familiarity with current principles and technical platforms for monitoring cell growth profile and metabolic profile, etc., is expected.
• Familiarity with factorial experimental design and DOE software (JMP, Design-Expert, etc.) is desired.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $181,000.00 - $250,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet Bio is seeking an experienced Director/Senior Director of Medical Writing to manage, write and edit scientific, clinical and regulatory documents, communications and publications. This key role supports Adicet’s clinical and regulatory communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.

Key Responsibilities

• Leads the development and authoring of clinical protocols, protocol amendments, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings
• Provides medical writing support for briefing documents, information requests, nonclinical summaries, Development Safety Update Reports and additional documents intended for submission to HA.
• Leads the development and authoring of abstracts, posters, slides of clinical study data at conferences and the development of primary manuscripts for publication in peer-reviewed journals.
• Collaborate with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in the planning and preparation of the above documents according to company and agency guidelines in order to support drug development under strict timelines.
• Facilitates adjudication meetings and issues resolution.
• Organizes, conducts, and leads cross-functional document development meetings.
• Manage the work of other consultant or internal medical writers. This includes training and mentoring, in addition to participating in assessing workload and managing work assignments.
• Lead the Medical Writing team in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.

Qualifications

• Minimum of 5 years of experience in the biopharmaceutical industry, with 2 years of direct medical writing experience
• BA/BS required; master’s or doctorate degree in life sciences preferred
• Excellent written and verbal communication skills with the ability to interpret and present scientific data concisely, accurately and with attention to detail
• Ability to work cross-functionally
• Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat
• Awareness of FDA regulations, ICH guidelines, Good Clinical Practices, and the drug development process
• Awareness of American Medical Association Manual of Style
• Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment with limited supervision

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $181,000 - $273,000 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet bio is seeking an experienced Director of Clinical Sciences who is interested in being part of our mission to develop novel gamma delta CAR T cell therapy for the treatment of hematologic malignancies and solid tumors. As an integral member of the clinical development team, this candidate would support clinical science deliverables for our pre-IND, or phase 1 programs. The ideal candidate would thrive in an innovative cross-functional environment where collaboration with other internal functions and external scientific/academic organizations is an integral part of the work. We are looking for someone who has prior experience in writing study related and regulatory documents, as well as reviewing, helping to analyze and communicating clinical data. Other experiences should include interacting with external stakeholders at congresses, leading regular study related meetings, SIVs, advisory boards and steering committees. Importantly, this individual should have a desire to proactively participate within a multi-disciplinary team with internal colleagues in a highly interactive, fast paced and scientifically oriented environment.

Responsibilities

• Review, analyze and summarize clinical data from clinical studies to support decision-making.
• Perform ongoing clinical review of safety and efficacy data.
• Provide clinical input for CRF design, statistical analysis plans and ICFs.
• Participate in internal and external meetings to facilitate development of our CAR T trials.
• Prepare and present data for scientific meetings (internal and external).
• Collaborate with internal/external stakeholders (regulatory affairs, statistics, translational medicine) to support trial objectives.
• Author clinical protocols, investigator brochures, amendments, other study related plans and CSR.
• Author and review clinical sections of regulatory documents and submissions (e.g., CSR, DSUR, etc.).
• Review eligibility criteria of patients in screening and response to site queries.

Requirements / Experience

• MD, Ph.D. or Pharm. D.
• Minimum of 2 years of biotechnology/pharmaceutical industry experience, preferably in immuno-oncology. Experience with cell therapies a plus.
• Strong ability to evaluate, interpret, graphically analyze and present complex clinical and scientific data.
• Strong interpersonal and communication skills.
• Experience authoring scientific/clinical sections of clinical research documents, including clinical protocols, DSURs, INDs, CSRs and other regulatory submissions.
• Ability to work with a multi-disciplinary team in a transparent and interactive/collaborative work environment.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $186,000.00 - $257,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet Bio is seeking an experienced Quality Assurance professional will be responsible to assess and monitor the health of the QMS for continuous improvement, while also leading cross-functionally in order to build a culture of quality across the internal and external manufacturing sites. This leader will oversee quality systems and health authority inspections, internal audit program, document control, records management and training for the manufacturing site. Reporting to the Quality Head, the Director Quality Systems and Compliance will be responsible for implementing world class quality system processes and operations to ensure Adicet Bio exceeds the highest level of compliance. This leadership role provides strong strategic direction for the application of Adicet’s Quality Management System (QMS) expectations in support of manufacturing for Adicet clinical drug product and excipients.

In this key position, the individual will develop, implement, manage, and maintain GxP (cGMP, GCP, and GLP) quality systems and will work across all disciplines (e.g., process development, manufacturing, clinical development, research, and regulatory affairs) to ensure that Adicet’s ongoing development program maintains regulatory compliance with local, state, federal, and international health authority requirements. Adicet’s development programs involve novel cell therapies which present opportunities for unique product manufacturing, quality, and regulatory strategies. The ideal candidate should have experience in the area of cell therapy and/or biologics and knowledge of the pertinent regulations and how they apply to these fields.

Key Responsibilities

• Implement Adicet’s overall Quality Management System (QMS) and quality manual, policies and procedures for the site. Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations.
• Provide cross functional quality leadership and act as a GXP compliance subject matter expert. Serve as the site’s Quality process owner for, at a minimum, Deviation Management, Change Management, Notifications to Management / Escalations, Material Review Boards, Complaints, Quality Management Reviews, and Health Authority reporting.
• Oversee the performance and effectiveness of the QMS programs listed as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity. Lead Management review meetings and monitor the state of control of Adicet’s QMS in the internal and external manufacturing sites.
• Evaluate business goals, identify improvement opportunities, utilize critical thinking, and apply problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.
• Support regulatory filing requirements for INDs, CTAs, NDAs and other regulatory compliance communication.
• Work with manufacturing quality assurance and technical functions in batch record audits and assure proper batch release and/or disposition.
• Oversee audits/inspections, including preparation, execution, reporting, and follow up to any finding.
• Provide trend analyses, and KPI/metrics to peers and senior management.
• Review and approve development study protocols and reports.
• Organize and implement a training program for Adicet staff to maintain compliance with regulations and SOPs.

Qualifications

• Scientific degree (chemistry, biology, pharmacy or related, pharmaceutical or engineering sciences).
• At least 8 years of experience managing the quality aspects of cell therapy and / or biologic products, including manufacturing and technical qualification, analytical testing, and product release in a clinical stage pharmaceutical or biotechnology company.
• Excellent working knowledge of cGMPs, FDA regulations (21 CFR Parts 210, 211), ICH Guidelines and practical experience in auditing practices and procedures.
• Working knowledge of GLP, GCP, GTP, GDP and relevant ICH guidelines preferred.
• Strong supervisory skills with ability to thrive in a matrix environment.
• Self-motivation, good judgment, strong follow up, organizational, analytical, and problem- solving skills.
• Strong team orientation, with excellent written and oral communication skills.
• Other: Identify and support a Qualified Person (QP) in accordance with directive EC/2001/83, when required.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $162,000 - $283,000 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet Bio is seeking an exceptionally talented and motivated individual to join our team as Associate Director/Director, Regulatory Affairs. This position will be responsible for developing and executing innovative regulatory strategies in support of the nonclinical and clinical development for our early development pipeline products within the Regulatory Affairs department. In this lead, direct role, the successful candidate will provide dynamic leadership and direction to senior management and product development teams and will work in close partnership with the nonclinical and clinical leadership to achieve development milestones in an efficient and compliant manner. The role would require a strong scientific background with understanding and experience in GLP, GCP, and relevant regulatory guidelines to contribute to and shape the overall clinical development strategy.

The successful candidate will interface cross-functionally in a matrixed environment to integrate nonclinical and clinical plans with overall development plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.

Key Responsibilities

• Manage all aspects of nonclinical and clinical regulatory strategy development for Adicet products (early- to late-stage/registration/post-market).
• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance.
• Identify and assess regulatory risks and critical-path activities associated with nonclinical and clinical development programs and work to identify regulatory strategies to mitigate risks.
• Monitor and analyze regulatory agency activities regarding nonclinical and clinical development and assess potential impact on the Adicet development programs and understand the regulatory landscape.
• Serve as Regulatory Lead on cross functional project teams to achieve project milestones/goals.
• Lead global regulatory submission development - Responsible for planning, coordinating, and developing high quality, compliant and timely regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).
• Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.

Qualifications

• Master’s degree in life sciences, or advanced degree preferred.
• Prior experience with cell or gene therapies
• Prior experience in oncology drug development
• 10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
• Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
• Ability to lead matrixed teams, drive and influence effective collaborations.
• Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience.
• Initiative-taking, self-disciplined, and able to function independently as well as part of a team.
• Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $165,000.00 - $250,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

Adicet Bio is seeking a highly motivated team member who will be a significant contributor to the protein sciences team. This person will work with other members of the team to design and optimize approaches to create customized Antibody conjugations to a variety of PEG, hydrogel, and nanoparticle scaffolds. The candidate will also contribute to routine expression, purification, and characterization for a wide variety of ongoing pipeline projects. The ideal candidate will have excellent communication skills and a desire to mentor other scientists at the bench.

Key Responsibilities

• Work alongside other team members in protein sciences to express, purify, and characterize diverse proteins ranging from antibodies to antigens to engineered protein molecules for ongoing programs in research. ?
• Lead efforts to design and implement novel conjugating antibodies and/or proteins to beads or other small molecules.
• Develop assays to characterize the properties of Antibody-PEG conjugates and/or hydrogels.
• Train and serve as a mentor for other scientists on the team.
• Maintain updated lab notebook and records.

Qualifications

• At least 3-5 years of experience in closely related field required. Title will be dependent on previous experience.
• BS in chemistry, biochemistry, or chemical biology. Master’s degree preferred but not required.
• Strong desire to work at the bench.
• ands-on experience performing and/or optimizing purification strategies for challenging proteins.
• Prior hands-on experience performing protein conjugations for ADC development a strong bonus.
• Previous hands-on experience conjugating proteins to fluorophores, PEGs, or nanoparticles.
• Experience with site-specific protein conjugations or ADCs a bonus.
• Previous experience and/or familiarity with HPLC-SEC (Agilent), FPLC (AKTA Pure or Avant), MALS (Wyatt).
• Desire to work in a fast-paced environment on challenging research projects.
• Prior experience in mammalian cell culture (293 or CHO).
• Highly organized and detail oriented.
• Ability to manage multiple projects and collaborate efficiently with cross-functional teams.?

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $ 105,000.00 - $145,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

We are seeking a highly motivated candidate with a background in immunology to join the Adicet Research Team. The ideal candidate will have in-depth knowledge of T cell immunology and CAR-T cell development. The candidate will work as a part of a multidisciplinary team, utilizing the latest technologies for cell engineering and contributing to the generation of novel cell-based therapeutics for the treatment of cancer.

Responsibilities

• Carry out genetic modifications of gd T cells using both viral and non-viral methods.
• Cell culture (primary cells, cancer cell lines, CAR-T cells) for cell-based assay development (proliferation, cytokine release, cytotoxicity).
• Design, perform, and analyze in vitro experiments to characterize CAR-T cell function.
• Apply nucleic acid, protein, and reporter-based technologies (e.g., Nanostring, Luminex, Incucyte) for assay analysis.
• Perform multi-color flow cytometry (cell surface/intracellular staining, cell sorting)
• Maintain detailed records of experimental protocols, results, and inventory in an electronic lab notebook.
• Analysis and interpretation of experimental data.
• Present at group meetings.
• Utilize software tools to support data analysis tasks (e.g., Prism, FlowJo, Word, Excel and PowerPoint).

Qualifications

• BS or MS/MSc in biological sciences or a related field.
• 1 to 3 years of relevant academic and/or industry experience.
• Experience in primary cell culture and aseptic tissue culture techniques is required.
• Experience with cell-based assays (e.g., CAR-T and cancer cell co-culture, cytotoxicity, cytokine, proliferation, and serial stimulation assays).
• Experience with multicolor flow cytometry and data analysis on FlowJo is a plus.
• Viral and non-viral gene-editing on primary T cells or NK cells experience is preferred.
• Ability to work collaboratively, multitask and meet deadlines in a fast-paced environment.
• Openness to flexible working hours is preferred.
• Organized and disciplined record keeping is essential.
• Team player with excellent verbal and written communication skills

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $83,000.00 - $115,000.00 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

• Oversee and participate in the execution of viral vector manufacturing according to defined SOPs and manufacturing batch records within a cleanroom environment
• Operate and troubleshoot process equipment such as TFF skids, incubators, functionally closed system bioreactors, and controlled rate freezers
• Buffer preparation
• With Quality Assurance, supervisor, and Facilities, ensure preparedness for runs in terms of equipment readiness and operator training
• Troubleshoot OOE and OOT issues during routine manufacturing
• Manage, provide guidance, and support a team of manufacturing associates
• Collaborate with MS&T to refine MBRs and with SCM to generate supply orders to support BOM
• Must possess high degree of learning agility
• Support Quality Management system including but not limited to deviation investigations and risk assessments
• Understand and implement safety procedures.

• Bachelor’s degree in a biological science, engineering or related science discipline with 1 – 3 years of experience in a clinical processing and/or cell culture/purification operations preferably in a GMP environment; or equivalent combination of education and experience.
• GMP experience in a cleanroom for cell therapy products required with previous experience in gown qualification, aseptic behavior, materials kitting, and aseptic flow of materials
• A strong background in cell culture and/or purification
• Buffer preparation knowledge
• Working knowledge and understanding of GMP, GCP, GDP, and relevant FDA guidelines.
• Process-oriented with strong analytical skills for risk identification and management.
• Excellent verbal and written communication skills and can confidently communicate with all levels of staff in this collaborative work environment.
• Self-motivated and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Proficient in MS word, Excel, PowerPoint, Outlook and warehouse management software.

• Independently design and execute studies to optimize methods for iPSC differentiation into functional gamma delta T cells
• Develop and establish assays to characterize the molecular and functional phenotype of iPSC-derived gamma delta T cells
• Investigate novel cell engineering technologies to functionally enhance the efficacy of gamma delta T cells
• Analyze and interpret experimental data and summarize key findings to drive critical decision making.
• Collaborate across functional groups, manage multiple projects while adhering to timelines
• Provide mentorship and support to direct reports and other team members

• Ph.D. in Immunology, Tumor Immunology, or related field with a minimum of 3+ years of post-doctoral or industry experience
• Strong background in T cell biology including differentiation, activation pathways, and effector mechanisms
• Knowledge and experience with iPSC reprogramming and differentiation into T cells
• Experience with viral and non-viral gene editing techniques in primary T cells
• Expertise with molecular and immunological assays to characterize T cell molecular and functional phenotypes and including, but not limited to, PCR/qPCR/ddPCR, RNA-Seq, multiparameter flow cytometry, cytokine release assays, and cytotoxicity assays
• Excellent interpersonal, verbal, and written communication skills
• Strong management skills and ability to create, influence, and lead a team
• Self-motivated, innovative mindset, and focused; able to collaborate with colleagues to accomplish project goals

• Serves as the clinical lead on one or more clinical trials.
• Designs, develop and write clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with internal team members.
• Serves as a medical monitor, including evaluation of the safety and efficacy in ongoing studies in close collaboration with the clinical operations teams.
• Interfaces and leads interactions with investigators and thought leaders via society meetings, advisory boards, and investigator meetings.
• As the medical lead of a study, responsible for ensuring data quality, summary and writing of clinical study report.
• Works on regulatory submission documents.
• Attends scientific meetings pertinent to clinical development activities.
• Maintains clinical and scientific awareness in area of expertise.

• MD with 3+ years of industry experience designing, leading and managing clinical studies in hematologic malignancies; experience in cell therapy or immuno-oncology is a plus.
• Demonstrated understanding of the drug development process, able to execute and deploy drug development strategic plans and to provide technical and strategic advice. 
• Strong knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.
• Ability to work independently and effectively leading and participating in teams.
• Strong interpersonal capabilities, communication skills and leadership skills. 
• Excellent technical writing and scientific presentation skills.
• When appropriate, willing to travel to society meetings, visit investigative sites and attend investigator meetings. 

• Responsible for developing and leading a highly functional and scalable CDM organization, including formulating CDM strategy, operations, infrastructure, and processes.
• Provide leadership, direction, and expertise to CDM staff; foster and promote the long-term development of the CDM team; drive a culture of collaboration and continued improvement; and work closely with other functional leads to maintain cross-functional operational excellence
• Provide oversight to contract research organizations (CROs) and vendors to ensure timely delivery and compliance with regulations regarding outsourced activities.
• Provide oversight for individual study data management documents.
• Lead the development and implementation of CDM SOPs, work instructions, standards, and best practices, and ensure compliance with SOPs, GCP, ICH guidelines, and other established guidelines of national and international regulatory authorities
• Assist data management audit and address audit observations Qualifications

• Bachelors or Masters in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields
• 15+ years of experience in CDM within pharmaceutical/biotechnology industry
• 5+ years of direct line leadership with proven ability of successfully building a CDM team and overseeing multiple clinical trials
• Extensive experience in working successfully with internal and external partners, and managing external vendors and CROs
• Deep expertise in CDM and associated technologies, processes and tools, and willingness to learn, develop, and implement innovative data management methodology
• Extensive knowledge of clinical development processes from early to late-stage development, and experience supporting eCTD submissions through the creation of CDISC/SDTM standard datasets is required.
• Solid understanding of regulations and guidelines including GCP, CDASH, CDISC as applicable to CDM
• Oncology clinical trial experience strongly preferred.

• Ensure all vendor invoices are booked and allocated accurately with sufficient evidence in compliance with GAAP and company policy.
• Process two-way and three-way match of invoices in Accrualify in paperless environment
• Review and process employee expense reimbursements and ensure expenses have proper supporting documentation
• Research and collaborate with employees and vendors to resolve invoice and purchase order discrepancies
• Correspond with vendors regarding invoice, payment, and other finance-related inquiries
• Manage monthly credit card reconciliations for corporate cards
• Support accurate and timely completion of A/P month, quarter, and year-end close. This includes reviewing monthly vendor statements, open POs, accruals, and reconciling goods received but not invoiced
• Assist with weekly processing of cash disbursements, including preparation of ACH and wire batches
• Ensure sales and use tax is accrued and paid in a timely manner
• Support interim and year end audit process (internal and external)
• Maintain current and accurate vendor records
• Identify and escalate priority issues timely with management
• Other tasks as assigned

• Bachelor’s degree in Finance, Accounting or Business Administration
• Minimum of five years A/P experience
• High degree of accuracy and attention to detail
• Ability to be organized and manage multiple projects while exemplifying stellar interpersonal skills
• Excellent communication skills (written and oral)
• Proficiency with Microsoft Office (Outlook, Word & Excel) and Acrobat DC
• Experience with Accrualify and Dynamics Business Central, a plus
• Ability to work with high volume of transactions in a fast-paced environment
• An aptitude for learning and managing ERP data structures and reporting capabilities
• Results and goal-oriented mindset with an opportunistic eye towards process improvements
• Strong ability to prioritize and organize work. Agility to adjust quickly to new priorities
• Ability to collaborate and communicate effectively

• The successful candidate will contribute to the advancement of ADICET Bio's cell therapy platforms by developing multi-color flow cytometry, cell-based cytotoxicity, viral titer, potency and qPCR assays used for evaluation of the quality of drug substance (DS) and drug product (DP).
• Involve in cross-functional team projects relating to assay design, development, and technology transfers.
• Opportunity to learn and contribute to the development of ELISAs and ddPCR assays as a part of DS/DP release testing assays to facilitate advancement of the cell therapy pipeline.
• Serve as an SME for Flow-cytometry, cell-based assays, qPCR, viral titer, potency, data analysis and interpretation.
• Prepare standard operating procedures (SOPs) and technical documents for tech transfer purposes to internal QC team, external CROs and CMOs.

• Advanced degree with background in Immunology or Virology or Cell and molecular biology related life science areas is required.
• PhD degree with 0+ years or Master's degree with 3+ years of industry experience is required.

• Owning the creation and ongoing evolution of the development strategy and overall timeline which leads to successful timely commercialization
• Ensuring strategic input from all critical functions are incorporated to ultimately deliver regulatory filings, which achieve the approved target product profile.
• Significant development expertise which enables full understanding of the work needed to meet corporate goals.
• Ensuring alignment of program team objectives with corporate business objectives
• Partnering with Research, Clinical, and Medical Affairs to develop effective working relationships with key opinion leaders, and leveraging their input in partnership with the Program Management Lead
• Continually evaluating and refining the program’s business plan and rationale
• Identifying, evaluating, and recommending Life cycle opportunities
• Ensuring a comprehensive plan for IP protection and freedom to operate is established
• In partnership with the Program Management Lead:
  • Building effective teams- setting clear expectations for team and team member’s roles and responsibilities, promoting team cohesiveness to optimize performance, and mediating conflict resolution
  • Proactively identifying potential issues/risks and working with the team/functions to develop mitigation strategies
  • Working to remove all barriers for the team so that they can be successful
  • Elevating issues that cannot be resolved by the team
  • Facilitating effective team decision-making
  • Representing the team to the PC and ELT.

• 15+ years multi-disciplinary experience in the pharmaceutical/biotechnology industry
• 12+ years managing/leading cross-functional teams or projects
• 5+ years Program Leadership (or functional management) experience
• Broad understanding of drug development industry and regulations pertaining to different aspects of drug development (ie, GxPs, clinical study design, regulatory filings, IP, reimbursement, compliance, etc).
• Experience leading a program through a significant milestone (i.e. major regulatory submission, Phase 3 implementation, launch)
• Has managed complex projects with ambitious milestones in high pressure circumstances, achieving desired results
• Has successfully managed collaborations, alliances or other relationships through influencing without authority
• Proven experience in interpreting and communicating complex datasets (scientific, business, financial), clinical trial designs, publications
• Previous people management experience desired
• Oncology and/or Cell Therapy experience required
• Advanced degree required (PhD, MD, PharmD)

• Partners with the Program Leader to optimize team effectiveness and decision making. Works with the Program Leader and team to develop a detailed project plan and associated budget.
• Creates and drives timelines to keep program(s) on schedule. Prepares program timelines (Gantt chart) identifying all significant activities, dependencies, resources and milestones. Assists the Program Leader in planning, coordinating and tracking cross-functional and external activities for the Adicet Bio program. Continual review and analysis of critical path activities.
• Facilitates highly effective team building and communication. Works with the Program Leader and team to develop and distribute agendas for regular team meetings. Helps facilitate meetings and keeps them on track. Provides meeting minutes and drives follow up on Action Items. Proactively, and independently, identifies and resolves program team challenges.
• Performs effective risk management assessments with the Program Team, the Program Leader, and stakeholders.
• Drives information flow and communicates program status to all stakeholders in collaboration with the Program Leader. Produces regular status reports (milestones, status, issues, decisions), following review by the Program Leader and Program Team, for senior management.
• Reviews and proposes revised program work plans to accommodate changes in technical, marketing, or business objectives.
• Consolidates and reports on program budget. Works with the team and functional areas to prepare the annual (and longer range) program budget. Provides budget forecasts as requested.
• In cooperation with functional managers, ensures that resources assigned to the program are adequate to meet program objectives and identifies resource constraints.
• Maintains effective communication with the program team through oral and written correspondence and ensures adequate documentation of each communication.
• Creates and maintains an appropriate electronic platform for reporting and documentation of relevant program information, records, etc.
• Prepares information with appropriate input from program team members for internal as well as external partner review/governance meetings.
• Interfaces internally by acting as a liaison and facilitator of cross functional teams (ie, Clinical Development, Clinical Operations, Technical Operations, Regulatory, Quality Assurance, Finance, etc.) in planning and executing trials.
• Interfaces externally with collaborators, vendors, contractors, and consultants to ensure communication and deliverables in accordance with planned program objectives.
• Serves as a resource for other Program Managers as appropriate. May manage other junior Program Management staff.
• Assists team members in preparing for advisory board activities and other external meetings as appropriate.
• Develops and shares knowledge of current therapeutic environment and drug development trends as needed.
• Contributes to the development of the Program Development Department through introduction of new tools and processes for continuous improvement.

• Advanced degree (PharmD, PhD) is required.
• 10+ years of work experience within industry, 8+ years of Program/Project Management experience, within a matrixed pharmaceutical or biotechnology organization. PM Certification is a plus.
• Clinical development project planning experience is required. Understanding of product commercialization processes is highly desirable.
• Oncology experience is highly desirable.
• Cell therapy experience is highly desirable.
• Proactive mindset with strong leadership, facilitation, teamwork and influence management/negotiation skills.
• Excellent verbal and written communication skills as well as exceptional organizational capability.
• Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.
• Ability to drive program plans and timelines (across multiple functional areas) is essential. Proven success in goal setting, prioritization and time management is required.
• Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired.
• Experience working with external partners is highly desirable.
• Experience actively participating in a steering committee or joint development committee for pharmaceutical, biotech, or medical device product development is highly desired.
• Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Familiarity with developing budgets and forecasting is highly desirable.
• Keen insight, independent judgment and tactful discretion are required.
• Must be able to demonstrate strong analytical and problem-solving capabilities.
• Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.

• Ensure the successful transition of development candidates into clinical assets through the strategic scoping and curation of nonclinical study packages, tailored for cell therapies, supporting safety, toxicology, translational pharmacology & pharmacodynamic assays that enable clinical exploration of novel therapeutics.
• Oversee established internal teams of in vivo and ex vivo scientists and coordination of existing networks of external CROs as key resources for study development and execution.
• Oversee established internal vivarium operations and administrative team that manages our state-of-the-art in vivo facility.
• Support drafting of regulatory filings in collaboration with Adicet Bio’s Regulatory group and the strategic curation and delivery of key content for nonclinical sections of INDs/CTAs and related NDAs/BLAs
• Contribute to key interactions with regulatory agencies as the representative for nonclinical science (responses to queries, preparation of pre-meeting documents, attend teleconferences and meetings with Health Authorities, as needed)
• Continually review and monitor guidance, regulations and publications relevant to nonclinical development tailored to cell therapy
• Mentor scientists and actively promote a culture of enriching personal, professional,
• Contribute to cross-disciplinary Research Leadership Team by coordinating the overall platform development strategy efforts in conjunction with other research leadership peers
• Mentor scientists and actively promote a culture of enriching personal, professional, and organizational development
• Leads as an example for Adicet Bio’s mission, vision, and culture

• PhD, PharmD, or MD/PhD degree in immunology, pharmacology, pharmaceutical science, biology, bioengineering, toxicology, physiology or related discipline is required.
• 10-15+ years of experience pertaining to IND enabling activities and related disciplines, with a minimum of 5 years applicable experience in field of Cell and Gene Therapies.
• Requisite and evidenced expert contributions and broad experience in executing and curating summaries for module 4 related studies for successful IND/BLA applications in the field of Cell and Gene therapy
• Established capacity to oversee and guide focused and efficient study execution efforts to achieve meaningful outcomes supported by scientific integrity and innovative value
• Demonstrated scientific leadership experience, including demonstrated capacity to develop and mentor others
• Self-motivated, creative, and focused; able to work within a team and to collaborate with colleagues to achieve program goals
• Excellent interpersonal, verbal, and written communication skills
• Strong people management skills and ability to build, influence, and lead a team
• An outstanding track record of scientific accomplishments spanning the biologic field as demonstrated through scientific publications, presentations, patents, and contributions to nonclinical/translational peer groups or consortiums.

• Manage the framework for evaluating the company’s cybersecurity program and continual improvements roadmap
• Establish and improve security policies, procedures, and standards
• Develop and oversee a cybersecurity risk management program
• Provide management with information on real-time threats and vulnerabilities facing the organization and recommended actions
• Partner with business units to ensure that risk management processes and security standards are understood and consistently applied across systems, projects, and practices
• Raise organizational cybersecurity awareness and develop and deliver security training
• Implement, operate, and maintain internal security tools and platforms
• Oversee third-party cybersecurity technology and service vendors
• Execute projects on the cybersecurity roadmap within budget, scope, and timeline
• Act as the primary control point during cybersecurity incidents, investigating and responding as needed
• Maintain the Cybersecurity Incident Response Plan
• Perform risk-based internal and vendor security audits

• Bachelor’s degree in Information Technology or a related field
• 8 years of prior relevant experience including 4 years of leadership experience in a combination of information security, risk, and technology management
• Professional security management certification preferred (e.g., CISSP, CISA, CISM)
• Strong ability to identify needs, take initiative and prioritize work efforts, balancing operational tasks with longer-term strategic security efforts
• Expert at networks, operating systems, logical access controls, and preventive and detective security solutions with an accompanying understanding of system vulnerabilities and cyberattack vectors and surfaces
• Strong knowledge of common information security management frameworks and practices such as ISO/IEC27001, NIST, SOX, GDPR, and HIPAA
• Familiarity with GMP requirements for information technology infrastructure and computerized systems
• Demonstrated ability to drive projects with minimal oversight and following best System Development Lifecycle and Project Lifecycle practices
• Excellent verbal, written and interpersonal communication skills
• Ability to cultivate networks throughout different parts of the organization to create support and influence and drive cultural changes