Longevity Industry Jobs

Reporting to the Chief Medical Officer, the Contract (6-12 months) Sr. Manager of Safety/Pharmacovigilance Operations is responsible for providing oversight and day to day management of all activities pertaining to product safety and pharmacovigilance operations in clinical development, The Contract Sr. Manager of Safety/Pharmacovigilance Operations ensures that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for 4DMT products.

RESPONSIBILITIES:

• In collaboration with the CMO, support the safety governance oversight for all company products.
• Collect, synthesize and deploy relevant drug safety information on all programs within 4DMT models.
• Organize and lead ongoing safety data review and signal detection, management of serious adverse event reporting, aggregate safety reporting, management of risk-benefit profiles, risk management and mitigation plans for all clinical stage programs
• Directly oversees the PV vendors/service providers to ensure that they fulfill their accountabilities and responsibilities, which includes ensuring high quality and on time case processing and aggregate reporting, as well as ensuring appropriate documentation and governance frameworks are in place
• Act as a sponsor Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide input on case processing activities for 4DMT products
• Ensures that adverse events from spontaneous cases, solicited cases from studies and programs involving 4DMT products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies
• Collaborate with appropriate clinical operations, clinical development, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including authoring as appropriate and review of documents such as DSUR, IB, clinical study protocols, informed consent forms, DSMB charters/meeting materials, development plans, Safety Management Plans (SMPs) and INDs/CTAs
• Support SAE Reconciliation activities for all 4DMT ongoing studies
• Provide safety operations expertise to other 4DMT therapeutic functions
• Represent PV function in audits with health authorities and development partners
• In collaboration with QA, overseeing and support implementation of safety related CAPAs, as necessary
• Support development of training modules and provide training in Pharmacovigilance across the Company
• Other duties as assigned

QUALIFICATIONS:

• Experience in ophthalmology/gene therapy a plus

Education:

• RN or other clinical equivalent degree required with strong relevant work experience

Experience:

• 6+ years' experience in a Pharmacovigilance Operations role within the Pharmaceutical / Biotechnology industry
• Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations Previous experience managing PV vendors required

Skills:

• Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
• Ability to work collaboratively with the internal partners and ability to build relationships with clinical sites and outside vendors
• The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills are required
• Attention to details, able to proactively identify issues and propose solutions
• Excellent written and verbal communication skills

Physical Requirements of the Role:

• Sitting for prolonged periods of time working on a computer

Base compensation range:

Minimum

Maximum

National Range

$75.48/hour

$91.83/hour

Please note, the base compensation range and actual compensation offered to the final candidate is dependent on variety of factors: candidate's geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

We are seeking an intern for our R&D organization where you will be a member of the Biomarkers team. This role will be primarily onsite in the lab at our headquarters in Emeryville, CA.

RESPONSIBILITIES:

Hands on lab experience and training: 80% of TIME

• Training and shadowing scientists to learn techniques and lab safety
• Performing supervised hands on experiments/techniques to support vector characterization and non-clinical studies
• Additional duties as assigned

Meeting attendance and software/systems experience/training: 20% of TIME

• Attend department and project meetings to learn about activities and contribute to team discussions
• Summarize experiments/data via ELN and powerpoint presentation
• Learn to navigate corporate systems for purchasing, data management, HR, EHS ect
• Training in common scientific/corporate software systems such as ELN, MS powerpoint/excel/word/outlook, sharepoint, graph pad prism etc

QUALIFICATIONS:

• Senior standing or recent undergraduate in Science, analytical chemistry, biology, scientific commuting and biotechnology majors or equivalent
• Hard working young person ready to learn and apply themselves

Physical Requirements of the Role: (for more information on examples - https://tmhra.org/ADAToolkit/5-WriteADA-JobDescrip.pdf )

• Examples use or add your own or delete if not applicable
• Lifting X lbs, pass an annual visual test required by GMP lab with or without corrective lenses, bending, lifting, twisting...

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The Scientist position in Biomarkers group will focus on molecular biology assays including method development and sample testing. This entails learning existing methods, method & equipment optimization/troubleshooting as well as testing valuable clinical and non-clinical samples. The data generated by the new hire will inform biodistribution and PK in our clinical and non-clinical programs as well as determine the success of new vector products. This new scientist will also become the lead for our growing biobank effort and integration into advanced sample/data management software and associated tasks. The new hire will be expected to integrate into department and cross functional project teams as a molecular biology subject matter expert. The new scientist will be also expected to cross-train with other members of biomarkers team and 4D to share expertise and pick up new scientific techniques.

RESPONSIBILTIES:

• Design/Optimize/Perform molecular biology experiments: 50%
• Lead biobank effort: 40%
• Meetings, planning and administrative tasks: 10%

PRIMARY RESPONSIBILITIES:

• Support in-house method development and sample testing for DNA/RNA-based molecular biology assays to support exploratory clinical and non-clinical studies
• Lead 4D biobank effort/project: design and integration of bio-sample library into sample management software, inventory management and sample receiving/distribution
• Attend and contribute to meetings with external CROs, departmental meetings, cross functional and clinical team meetings
• Identify and implement innovative technologies to improve 4D biomarker strategy
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education & Experience:

• Ph.D. in related scientific discipline and 2+ years industry experience or MS/BS in related scientific discipline, and 4+ years industry experience

Skills:

• Proven expertise in ddPCR or qPCR, as well as other nucleic acid-based assays
• Prior experience in assay development or drug discovery is a plus
• Experience working with biospecimens (tissue, blood) is nice to have
• Excellent organizational capabilities and ability to work independently (with appropriate supervision)
• Strong analytical skills and attention to detail

Physical Requirements of the role:

• The candidate will be expected to be onsite for lab work 4-5 days per week as well as:
• Adhere to PPE requirements and complete all required safety training
• Adhere to 4DMT Covid protocols and policy

Base salary compensation range:

$125,000 - $142,000/year

Please note, the base salary compensation range and actual salary offered to the final candidate is dependent on variety of factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

We are seeking an intern for our TMF Operations Department where you will be a member of the TMF Operations team. This role will be: Remote-based

This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and 4DMT’s Standard Operating Procedures (SOPs) as appropriate.

RESPONSIBILITIES:

• Shadow the TMF Operations team to gain an understanding of their workflow and processes
• Participate in department meetings and contribute to team discussions
• Review and categorize documents obtained from internal and external sources according to a Study Specific TMF Index based on the CDISC TMF Reference Model
• Conduct quality control checks and maintain the electronic Trial Master File (eTMF) for assigned studies
• Enter and reconcile data in various clinical systems and tracking tools
• Address and follow up on quality-related findings
• Ensure essential documents are properly reconciled to prevent duplication

QUALIFICATIONS:

• Strong written and oral communication skills
• Ability to build effective relationships with trial center colleagues and staff
• Superior problem solving, deductive reasoning and decision-making skills
• Good time management and ability to prioritize tasks and accomplish set goals efficiently
• Excellent attention to detail and ability to maintain detailed and accurate records

Physical Requirements of the Role: Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

We are seeking an intern for our Portfolio and Product Strategy Department where you will primarily support Competitive Intelligence projects. This role will be: hybrid, at least one day in-office per week to be coordinated with the broader team

RESPONSIBILITIES:

Market Landscape Update and Analysis: 85% of TIME

• Utilize external databases and secondary resources (e.g., company websites, scientific presentations) to conduct analysis of competitor products to key 4DMT programs
• Update information, formatting and organization of internal competitive landscape slides

Ad-Hoc Assistance to Strategy Group: 15% of TIME

• Understand workflows related to collection and dissemination of competitive intelligence
• Assist in secondary research and analysis related to other ongoing strategy projects

QUALIFICATIONS:

• Senior standing or recent undergraduate with major in biological sciences or related field, or major in business with significant coursework in biology
• Interest in the intersection of life sciences and business
• Intellectual curiosity
• Proficient in secondary research skills and Powerpoint

Physical Requirements of the Role: Work is performed in an office environment and requires the ability to operate standard office equipment and keyboards. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; viewing a computer terminal; extensive reading.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

As Senior Manager of Investor Relations, Corporate Finance, and FP&A, you will be part of a team that will be responsible for the overall financial strategy and external face of 4DMT. You will play pivotal roles in the capital raising process, valuation of current and future products, annual budgeting process, periodic budget vs actual reporting, investor relations activities, and other ad hoc projects. This position reports to the Head of Investor Relations & Finance and works closely with the Chief Financial Officer and others in senior management. The role will be hybrid (:2-3 days per week in the office).

RESPONSIBILITIES:

• Work closely with CFO and Head of Investor Relations & Finance to develop the evaluation of strategic and business alternatives
• Drive the analysis of 4DMT’s capital structure, including supporting evaluation and execution of potential financing transactions (e.g, equity, debt, partnerships etc)
• Working with the internal strategy and business development teams, to develop financial support processes & valuation for transactions as needed
• Participate and lead select budgeting, forecasting, and long-range planning activities
• Prepare and publish monthly reports including budget versus actual comparisons
• Create Executive and Board level presentations
• Assist Head of Investor Relations & Finance with Investor Relations activities (e.g., drafting external facing materials such as corporate deck, data disclosure decks, press releases, Investor Day prep, researching peer company disclosures to aid in drafting process, maintaining Wall Street analyst consensus model)
• Manage ad-hoc requests and analysis to support executive management and finance group

FP&A / Corporate Modeling / Ad Hoc Analysis: 60% of TIME

IR: 30% of TIME

Various other Ad Hoc F&A projects: 10%

QUALIFICATIONS:

Education:

• Bachelor degree in finance or accounting, with MBA preferred
• Bachelor degree or MS/PhD in biological sciences (e.g, Biology, Biochemistry, or similar) highly preferred

Experience:

• 5+ years of relevant work experience (investment banking, management consulting, corporate strategy/finance, etc.) within the life sciences industry
• Excellent understanding of the biotechnology industry and the various functional areas
• Evaluating and analyzing complex financing and business initiatives
• Experience working with Senior Executives
• Experienced with licensing and business M&A valuation modeling

Skills:

• Excellent computer skills (Advanced Excel, Word and PowerPoint skills are required)
• High degree of initiative and ability to work independently
• Strong interpersonal skills and a team player is essential
• Excellent written and verbal communication skills; ability to work effectively with Senior Executives and with cross functional counterparts
• Exceptional problem-solving and quantitative/analytical skills

Physical Requirements of the Role: primarily computer use

• To maintain a healthy and safe workplace for all during the COVID-19 this role is expected to:
• Open to hybrid-based employee with occasional travel (2-3 times a year)
• Adhere to 4DMT Covid protocols and policy. This includes all employees and contractors must share proof of current vaccination status to work onsite.

Base salary compensation range:

Minimum

Maximum

National Range

$142K

$180K

Bay Area Range

$176K

$202K

Please note, the base salary compensation range and actual salary offered to the final candidate is dependent on variety of factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

4DMT needs a motivated, detail-oriented, and experienced Research Associate 2. This individual will join a growing Cell-Based Assay (CBA) team to develop, optimize and validate cell-based bioassays for the characterization, lot release/stability testing and formulation assessment of AAV-based gene therapy drug substances and drug products. Working cross functionally with Research, Discovery, Process Development, Manufacturing, Quality, and Facilities the Research Associate II will support the life cycle of bioassays for current and new candidates during early- and late-stage GMP production.

Responsibilities

Lab work/experimental/data analysis 70% of TIME

• Maintain cell lines, prepare, and qualify cell banks using aseptic techniques with emphasis on adherent mammalian cell culture systems.
• Develop, optimize, and execute bioassays including cell-based, nucleic acid-based, ELISA, and enzymatic assays with a strong scientific understanding of the analytical procedures and applicability of the emerging or existing assay platforms.
• Understanding phase appropriate GMP requirements for AAV based gene therapy products.
• Perform under limited supervision routine testing of samples for characterization, Process Development support, and QC release/stability purpose.
• Provide feedback and/or suggest modifications to operational procedures.
• Assist with troubleshooting of analytical procedures and equipment problems; work with Facilities to assist with calibration, maintenance, and operation requirements of analytical equipment.
• Assist with the new facility expansion and equipment validation activities as needed.

Paperwork/documentation 30% of TIME

• Complete and submit experimental records following Good Documentation Practices, cGMP, and corporate policies to meet both operational and compliance requirements.
• Contribute to experimental protocols, reports, internal documents including SOPs, lab records, deviations, and investigations as appropriate.
• Maintenance of lab inventories and update database for designated project(s).
• Work closely with supervisors and cross-functional teams for setting up and following the testing schedule to meet timelines for products release, stability, and characterization purposes.
• Work closely with Materials Management to keep the reagents and lab supplies inventory stocked properly and within expiration.
• Follow all Quality and Safety procedures, including deviation and non-conformance reporting. Support deviation investigations and lab maintenance.
• Other Duties as Assigned.

Qualifications

• Bachelor’s degree in a relevant area of life sciences specialization (bioprocessing, chemical engineering, biochemistry, cell/molecular biology or similar).
• 2+ years of experience with Cell based assays and analytical procedures
• Exposure to Quality Control Processes/Regulations - Preferred
• Ability to adapt and work in a small company environment.

Required Skills:

• Proficiency with Cell/Tissue culturing and aseptic techniques.
• General understanding of molecular, cell and/or viral biology.
• Hands-on experience and strong understanding of the technical concepts in immunoassay (Western Blotting, ELISA) and molecular based techniques such as ddPCR.
• Attention to detail, quality, and compliance with strict adherence to test procedures and protocols.
• Ability to learn new technologies and processes in a timely manner.
• Must be a team player with analytical mindset, detail-oriented critical thinker, exhibit a readiness to meet project timelines and challenges in a dynamic fast-paced environment.
• Strong written and oral communication skills with demonstrated ability to present scientific ideas and information and data effectively via one-on-one discussions and team meetings.
• Basic math and familiarity with Excel, Word, and PowerPoint.

Preferred Skills:

• Cell-based potency assays experience in the AD/QC environment.
• Hands-on experience with SDS-Page/Western Blot, protein-protein interactions, and flow cytometry.
• Experience in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DoE) principles as well as data analysis and statistics.
• Experience with bioassay and/or statistical software such as SoftMax Pro, PLA, GraphPad, Minitab, JMP or Spotfire.
• Working knowledge of regulatory and industry guidelines in CMC analytical development.

Reports to: Sr. Scientist, Cell-Based Potency Assays AD/QC

Physical Requirements:

• Capable of repetitive work (pipetting/liquid transferring).
• Ability to lift, dispense, push and/or pull items with an average weight of 25 pounds.
• Ability to sit or stand for extended periods of time and intermittent walking to gain access to work areas.
• Ability to use a computer, hard copy materials and to complete paperwork activities (finger dexterity, vision).
• Hearing sufficient to communicate with individuals by telephone and in person.
• May be required to work during non-regular hours.
• Capable to be tested for COVID-19 and adhere to 4DMT Covid protocols and policy.

Base salary compensation range:

Minimum

Mid-point

Maximum

$75,000/year

$85,000/year

$96,000/year

Please note, the base salary compensation range and actual salary offered to the final candidate is dependent on variety of factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

• Perform testing in support of process development
• Perform testing for release and stability under GMP
• Maintain accurate and well-organized laboratory records
• Generate technical reports using statistical analysis
• Review and present analytical data to cross-functional teams

• Transfer and optimization of analytical methods for use in Quality Control
• Drafting of analytical Standard Operating Procedures
• Drafting, execution, and reporting of analytical method qualifications

• Maintaining a GxP-compliant testing laboratory
• Coordination and planning of Stability Testing
• Organization and maintenance of reference materials

• MS degree in Biochemistry, Biology, or related field OR
• BS degree with 3+ years of experience
• Experience working within Quality Control within a regulated industry
• Strong background in assay qualification/validation under ICH Guidelines
• Knowledge of viral gene therapy (adeno-associated viral vectors) preferred
• Successful demonstrated ability to work independently and work with others in designing and developing experiments, analyzing and interpreting data in a rigorous way
• Ability to multi-task and support more than one project simultaneously.
• Understanding and knowledge of key scientific software programs such as SoftMax/QuantaSoft
• Understanding and knowledge of regulatory requirements for biologic products
• Strong organizational, analytical, and problem-solving skills
• Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via one-on-one discussions, team meetings, and partnership interactions
• Experience working under GXP documentation

• Sound understanding of scientific principles
• General understanding of compendial testing, ICH qualification/validation
• Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential
• Must be a team player, a strong critical thinker, exhibit a willingness to meet project timelines, and multitask effectively in a dynamic fast-paced environment under challenging timelines
• Proficient or familiar with Microsoft-based Windows programs: Word, Excel, and PowerPoint

• Perform standard in vitro immunogenicity assays using primary human cells evaluating adaptive T and B cell responses to 4DMT AAV vectors and their transgenes. 
• Establish functional assays using primary human NK cells, macrophages, and other effector cells of the innate immune system to investigate activating properties of 4DMT vectors.
• Implement innovative in vitro assays to measure complement and Pattern Recognition Receptors such as TLR2 & TLR9 activating properties of 4DMT vectors.
• Develop and validate platforms such as 3D lymphoid organoids for assessing the immunogenic potential of AAV vectors and transgenes.
• Work closely with the Biomarker Group and contribute to high-priority work requiring assay development and molecular biology support.

• Identify and select CROs that will provide the best service in terms of technology, timeline, and cost for the study objectives.
• Develop immunogenicity study plans with CRO by writing SOWs and negotiating timelines and budgets.
• Monitor and review the progress of the study and provide regular updates to supervisor and stakeholders.
• Review, summarize and provide recommendations after the conclusion of the study to the supervisor and stakeholders.

• Act as liaison for the Immunology department in project team meetings and if deemed appropriate lead pre-clinical technology projects.
• Working with Immunology head, providing input on immunogenicity risk assessment and management in project leaders.
• Communicate to project leaders fit-for-purpose and stage-appropriate immunogenicity assessment strategies and approaches for preclinical and development projects.

• Ph.D. in Immunology with preferred specialization within innate immunology, viral immunology, or transplantation immunology
• Minimum of 2 years of direct experience in cellular immunology research within academia, biotech, or large pharma industry
• Experience in cell-based assay development - Preferred
• Familiar with bioinformatics - Preferred

• Expertise in the handling of human PBMC, isolation, and culture of T, B, and NK cells, monocytes, macrophage, and dendritic cells.
• High-level competency in flow cytometry, ELISpot, Luminex or equivalent, and co-culture activation techniques.
• Competency in basic molecular biology and biochemical techniques including PCR and ELISA.
• Strong statistical analysis and data interpretation skills.
• Able to manage multiple projects simultaneously and work in a team setting
• Good verbal and written communication skills
• Physical Requirements of the Role: (for more information on examples - https://tmhra.org/ADAToolkit/5-WriteADA-JobDescrip.pdf )

• 4 days in the lab, 5 days in the office
• Adhere to 4DMT Covid protocols and policy