Longevity Industry Jobs

This is a critical position in the regulatory affairs team, reporting directly to Chief Regulatory Officer. This position serves as Humacyte’s liaison to the US FDA for assigned projects in clinical development. Internally, this role functions as Regulatory Lead and works with multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and development products. This role also serves as a Regulatory strategist and is responsible for proactively developing and executing regulatory strategy for product in early and/or late stage of development.

Major Accountabilities:

• Co-Lead BLA submission effort across function 
• Serve as regulatory strategist and regulatory project lead or co-lead for assigned project 
• Accountable for establishing regulatory strategy for assigned project in US and global 
• Monitor and interpret FDA and other health authorities’ new policies and guidance, and assess the impact on company’s business 
• Could function as global regulatory lead, responsible for document preparation and interaction with other health authorities 
• Might coach and mentor junior staff supporting the regulatory team 
• Other responsibilities assigned when there is a business need 

Specific Skills:

• Recent hand-on experience with leading BLA submission, preferably to FDA/CBER 
• Recent experience with developing biologics 
• Have demonstrated successful submission and secured approval of BLA/NDA from FDA 
• Have functioned as FDA and other health authorities’ point contact 
• Have led formal meetings with FDA and other health authorities 
• Familiar with FDA content and technical requirement for BLA submission 
• Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs 
• Competent in leading across-function team and managing timelines 
• Able to work under tight timeline and high stress situation 

General Skills:

• Able to communicate effectively in English, both verbally and in writing 
• Excellent communication and interpersonal skills 
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook 
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others 
• Excellent organizational and time management skills with ability to set own priorities in a timely manner 
• High degree of flexibility and adaptability 
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook 
• Must be able to work as needed to meet tight deadlines and at peak periods 
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills 
• Demonstrated ability to work in a cross functional team 
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements 
• Always observe safety precautions and regulations in all areas where duties are performed 
• Responsible for reporting all safety hazards and potential unsafe working conditions 
• Ensures Humacyte or other required trainings/certifications are up to date 
• Represents the organization in a positive and professional manner 
• Reports to work on time and as scheduled 

Qualifications:

• Graduate Degree in Life Science is required. Ph.D, MD or Pharm D in Life Science highly preferred
• At least 5 years of regulatory project lead experience is required
• Experience leading a BLA filing is strongly desired

Perks:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**

The Senior Manager, Supply Chain Operations plays a key role in the movement of materials (Raw and Finished Goods) within the Humacyte network through strategy and oversight of Order Fulfilment, Transportation and Warehousing. Responsible for the development and management of shipping lanes. Responsible for all aspects of receipt, storage, and issuance of materials. Develop, implement, and manage Supply Chain Operations’ strategies, objectives, and policies. Ensures that the correct product is delivered at the correct point in an optimal manner. 

Remote Work Designation:  Not Remote

Major Accountabilities:

• Ensure customer sales orders, Internal Sales Orders (IRF), and manufacturing orders are processed within the agreed lead-times 
• Utilizes in depth understanding of departmental objectives and overall company objectives and translates these into strategic and tactical actions required to meet business objectives 
• Develop / maintain SLAs with internal and external customers and suppliers 
• Provide all aspects of personnel management for direct reports including recruitment of appropriate team members; scheduling; performance management; development of team members; engagement and retention 
• Site lead on the development, execution, and optimization of transportation lanes 
• Lead the qualification of transportation modes, lanes, and/or carriers 
• Be the voice of Supply Chain Operations in the Change Management Process 
• Ensure timely resolution of non-conforming events as well as corrective and preventive actions 
• Ensure optimization of transportation through strong influencing, negotiation, and collaboration skills 
• Ensure that effective and robust logistics related security, safety, and employee training programs are taken up 
• In collaboration with Supply Chain Leadership develop, implement, and drive the organization’s strategy for cultivating a fully engaged logistics workforce 
• Maintains receiving, warehousing, and distribution operations by initiating, coordinating, and enforcing program, operational, and personnel policies and procedures 
• Complies with federal, state, and local warehousing, material handling, and shipping requirements, enforcing adherence to requirements by all applicable team and cross-functional team members 
• Ensures oversight and control of inventory levels by conducting and/or reviewing physical counts, reconciling with data storage system 
• Ensures operational capacity is available in advance of organizational need. Collaboratively plans and implements new design layouts; equipment inspections; work orders issuance for repair and requisitions for replacement to align capacity in advance of demand 
• Achieves financial objectives by participating in the creation annual budget; scheduling expenditures; analyzing variances; initiating corrective actions 
• Completes warehouse operational requirements by scheduling and assigning employees 
• Partner with Demand & Supply Planning and Procurement to optimize order quantities and frequencies as well as minimize receipt exceptions 
• Develop/revise processes, work instructions, templates, and best practices to be used in operational processes 
• Other duties, as assigned 

Special Competencies:

• An excellent analytical and problem-solving skills 
• Ability to work collaboratively across multiple functions 
• Comfortable with team-based work structure; ability to demonstrate flexibility on the job 
• Demonstrates initiative, is conscientious and provides complete follow-through on areas of responsibility 
• Exceptional communication, listening and presentation skills 
• Proven ability to proactively build positive, collaborative relationships with multiple levels and parties 
• Ability to effectively manage multiple priorities and deliverables within an entrepreneurial work setting 
• Motivated and organized critical thinker with solid interpersonal and business communication skills 

General Competencies:

• Able to communicate effectively in English, both verbally and in writing 
• Excellent communication and interpersonal skills 
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook 
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others 
• Excellent organizational and time management skills with ability to set own priorities in a timely manner 
• High degree of flexibility and adaptability 
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook 
• Must be able to work as needed to meet tight deadlines and at peak periods 
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills 
• Demonstrated ability to work in a cross functional team 
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements 
• Always observe safety precautions and regulations in all areas where duties are performed 
• Responsible for reporting all safety hazards and potential unsafe working conditions 
• Ensures Humacyte or other required trainings/certifications are up to date 
• Represents the organization in a positive and professional manner 
• Reports to work on time and as scheduled 

Qualifications:

• Bachelor's Degree, required. Master’s degree, preferred desirable 
• 6+ years of relevant experience in Supply Chain Operations. Preferably in a Multi-Site GMP environment 
• Deep understanding of end-to-end supply chain 
• 5+ experience in transportation management inclusive of cold chain and validated assets 
•  Experience as the subject matter expert for Supply Chain for Warehouse Management and Enterprise Planning systems. Experience with Great Plains, Trace Link, and With Out Wires is desired 
• Proven experience leading teams in growth environment 
• Proven examples of lean journeys which resulted in driving standard and repeatable results validated by customer facing metrics. 

Perks:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruitment firms.**

• Support of the day-to-day duties and needs within the marketing and commercial department
• Work collaboratively with a strong team mentality and cohesiveness to ensure achievement of commercial and marketing department goals
• Assist with creative strategy for photography, videography, branding, and digital marketing
• Assist with graphic, branding, and logo creation, along with other creative assets
• Assist with content creation for all types of digital and social media channels
• Assist with media for company Intranet page and on-site digital signage
• Anticipate department needs, ensure efficient management of media and files, plan and schedule team meetings as necessary
• Participate in organizing, scheduling, and managing logistics for external tradeshow events
• Support external vendor relationships
• Creation, preparation, editing of PowerPoint presentations
• Ensure proper file management of digital media and department documents
• Provide superior customer service to departments throughout the company while assisting with interdepartmental projects
• Project management as assigned by direct manager
• Process expense reports as needed
• Other duties, as assigned

• Intermediate to advanced Adobe Creative Suite skills (Photoshop, Illustrator, Premiere, InDesign)
• Intermediate to advanced Outlook, Excel and PowerPoint experience
• Creative mind & eye, able to handle a multiple project workstream
• Experience with corporate social media content creation & copywriting
• Social media channel familiarity: Twitter, LinkedIn, Facebook, YouTube, Reddit, etc.
• Superior written and verbal communication skills
• Represent the organization in a positive and professional manner
• Excellent problem-solving skills while also having the ability to stay calm and solution-focused in high stress situations
• Constantly evaluates own performance and sees opportunity for growth
• Must maintain discretion and confidentiality regarding sensitive information with high professionalism and ethical standards at all times
• Superior customer service skills with both internal and external relationships
• Personable, reliable, flexible, quick thinking, solution oriented, and self-starter
• High degree of self-motivation and ability to multitask
• Strong interpersonal and professional boundaries
• Strong time management, organizational and prioritization skills
• Able to work both independently and collaboratively, able to both lead and follow as needed

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Associate degree, required. Bachelor’s Degree, preferred
• At least 2 years of experience in digital media creation, photo & video editing, social media content development, required
• At least 2 years working and being proficient in Adobe Creative Suite and Microsoft Office products, required
• Experience with content creation and copywriting for web, social, and print media
• Experience with media and file management

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Serve as a process expert on nonwoven Polyglycolic Acid (PGA) mesh within Humacyte, including manual and automated PGA scaffold entangling, base treatment, end-to-end bioreactor bag manufacturing, and Optical Coherence Tomography (OCT) analysis
• Serve as a process expert on nonwoven PGA mesh with third-party vendors, providing mentorship and troubleshooting as needed to ensure departmental and company deliverables are met
• Perform hands-on testing and troubleshooting of PGA mesh products to ensure departmental and company timelines are met
• Independently drive experimentation utilizing adherent mammalian cell culture to characterize cell-mesh interactions
• Support the scientific technical transfer of pipeline PGA mesh products internally and to third-party stakeholders
• Collaborate with the broader Process Development, New Product Development, Discovery, and Manufacturing Science & Technology groups to develop scalable, robust, translatable mesh-facing processes that vary in scope and complexity
• Train additional members of the Biomaterials, broader Process Development, New Product Development, and Discovery teams in methods of scaffold entangling, base treatment, and end-to-end bioreactor bag manufacturing
• Proactively anticipate necessary material and equipment needs for Process Development and New Product Development Luna launches, boxcar launches, and cell seeding experiments and coordinate with site services, Metrology, and external vendors to ensure timelines are met
• Summarize and communicate advanced or complex data and processes to both the Process Development group and to others within the company with limited supervision
• Demonstrate strong understanding of company projects and objectives and be able to translate those into technical objectives within a biomaterials framework
• Collaboratively author robust and detail-oriented SOPs, test procedures, protocols, and reports concerning nonwoven PGA mesh
• Collaboratively author reports detailing design of experiment, data collection, and results with limited to no oversight by management
• Collaborate effectively with internal and external groups, leveraging advanced knowledge to generate buy-in and advance personal learning
• Support necessary documentation, traceability, and process systems to ensure Phase I/II clinical material for pipeline products may be produced in a compliant manner in Process Development spaces at Humacyte
• Utilize subject matter expertise to support regulatory filings on pipeline products as needed
• Other duties, as assigned

• Passion and demonstrated ability for finding the underlying scientific story buried within large datasets and translating those findings into process improvements with robust scientific backing
• Demonstrated skills in a broad spectrum of bioprocess applications, indirect leadership, and mentoring of staff
• Routinely communicate findings and information to other team members and third parties; transparency and knowledge sharing is expected and practiced
• Comfort serving as the subject matter expert for vendor relationships for technical development projects
• Technical background in materials science with an emphasis on polymers or biotextiles
• Drive to actively collaborate with others both within PD and across departments and serve as a model by participating in activities that involve cooperating with others
• Knowledge of cGMPs and experience providing technical expertise in a cGMP bioprocessing environment
• Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
• Comfort communicating effectively, both technically and at a high level, with engineers, operators, technicians, and other subject matter experts
• Demonstrated experience in presenting complex processes and scientific data to both technical and non-technical audiences
• Excellent organizational and time management skills with an ability to set priorities in a timely manner

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Master’s or Ph.D. in bioengineering, biomaterials, biomedical engineering, biotextiles, chemical engineering, materials science, or related field, required.
• At least two years of experience with biomedical textiles, required
• Previous cell culture experience, specifically using adherent mammalian cells, and familiarity with sterile technique, required
• Experience with independent data analysis including use of appropriate statistical tests, required
• At least two years of experience in upstream process development, tissue engineering, or regenerative medicine, preferred.
• Strong background and techniques in aseptic processing, strongly preferred
• Demonstrated technical foundation of cell- and tissue- based products and a familiarity with cGMP manufacturing, preferred
• Experience with single-use technologies for cell expansion, including bioreactors and centrifugation systems, preferred
• Assay development experience for evaluation of biomaterials is a plus
• At least two years of experience in cGMP tech transfer is a plus
• Highly organized and motivated
• Proven ability to proactively build positive, collaborative relationships with multiple levels and parties
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
• Will be required to regularly to sit; stand for prolonged periods of time. Also, may occasionally be required to pull, lift and/or move up to 50 pounds

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies
• Please note, Humacyte does not provide sponsorship at this time.**

• Manage assigned clinical studies within designated budget and timeline
• Manage CRO and other vendors and day-to-day activities associated with the conduct of assigned clinical studies. This includes, but is not limited to, the following:
• Review and approve study plans and system set-up to ensure CRO and vendor compliance
• Ensure appropriate training of team members (including CRO and vendor staff)
• Regulatory packet review, approval coordination and site activation
• Monitor/co-monitor clinical trial sites and address operational issues
• Monitor applicable safety alerts and follow-up with Medical Monitor, CRO and sites
• Track subject metrics to ensure subject visits are occurring as expected
• Coordinate review of data listing and preparation of interim/final clinical study analysis reports
• Contribute to the design and development of Electronic Data Capture, Case Report Forms (CRF)and CRF guidelines
• Responsible for design, development and reconciliation of laboratory services
• Manage study budget including review and approval of invoices against contracts
• Oversee IP distribution to investigative sites
• Ensure that clinical studies are conducted in accordance with SOPs, GCPs, ICH guidelines, andall applicable regulations
• Ensure that clinical studies are conducted in accordance with executed contracts
• Key interface and resource for investigators (includes monitoring in the field as needed)
• Communicate directly with CRO and vendors regarding project issues, including enrollment strategies,protocol deviations, IRB issues, Investigational Product shipments and study related problems
• Participate in review of protocols, Clinical Study Reports, Investigator Brochure and other clinical orregulatory documents
• Participate in the selection process for CROs and other vendors as applicable
• Review clinical SOPs as needed
• Represent Humacyte at selected conferences and other meetings
• Collaborate with cross-functional departments in overall clinical study management
• Other duties, as assigned

• Excellent knowledge of ICH/GCP/FDA and other country specific regulations and guidelines for medical devices and/or pharmaceutical/biologic agents
• Strong background in conducting and monitoring clinical trials and pharmaceutical industry drug development process of Code of Federal Regulations 21 CFR 1271, a plus

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Bachelor’s degree, required. In relevant discipline, preferred
• Experience will be considered in lieu of education
• 3-5 years of Clinical Research Associate (CRA) experience or equivalent (CCRA preferred)
• Minimum 1 year experience as Assistant Clinical Project Manager
• At least 5-8 years clinical research experience
• Both sponsor and Clinical Research Organization (CRO) experience highly desirable
• Clinical background/experience preferable (e.g., nurse, NP, PA)
• Experience with regenerative medicine products, preferred

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Provide administrative assistance in day-to-day operations/functions for senior executive leadership, most specifically CMO, CRO, CCO
• Serve as gatekeeper in coordinating complex calendar management and working to resolve conflicts expeditiously
• Timely preparation and submission of expense reports
• Coordinating travel arrangements as requested
• Organize departmental, cross-functional, and external meetings including securing conference rooms, catering (as needed), coordinating calendars often in multiple time zones.
• Liaise with external business partners and vendors
• Invoice processing
• Process/Manage vendor contracts
• Filing scientific publications
• Creation, preparation, and editing of PowerPoint presentations and departmental budget spreadsheets
• Developing and issuing written communications
• Support the procurement process (Regulatory function) understanding the budgetary leveling
• Collaborating to plan and execute employee engagement activities
• Take minutes for larger departmental/functional meetings
• Plan and execute offsite meetings
• Other duties, as assigned

• Proficient in MS Office products (Outlook, Word, Excel, PowerPoint)
• Understand and operate virtual technologies (i.e., Zoom, TEAMS, SharePoint, Concur, Adobe, conference room A/V equipment)
• Excellent communication skills (oral and written)
• Professional/polished
• Collaborative spirit
• Superior customer service mindset
• Compassionate & independent thinker
• Outstanding capacity to multitask
• Highest degree of ethical standards (protect confidentiality)

• Biomedical/pharma or regulatory background
• High degree of proficiency in PowerPoint
• Career Administrator
• 8+ years executive support at the C-Suite level
• NC Notary
• Excellent problem-solving skills

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Associates degree required, +7 years of administrative experience
• Bachelor's Degree (preferred) + minimum 5 years of experience working at the Senior Executive level (vice president and above)
• 5 years of experience at the Executive Management (C-suite) level

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Creates statistical forecasts by data analysis and using input from internal and external customers, validates data, reviews statistical forecast models, and applies error analysis techniques to improve forecasting for both raw materials and finished goods.
• Develops finished goods and raw materials forecast in monthly/yearly buckets for the horizon needed to achieve company objectives.
• Measures forecast accuracy for key vendors and finds best forecasting method to achieve desired level of accuracy.
• Achieves consensus for operational demand forecasts by facilitating a collaborative planning process with all stakeholders (S&OP). Prepares relevant material to facilitate research and discussion.
• Independently prepares and communicates Key Performance Indicators (KPI’s) to management. These KPIs include but not limited to capacity, purchases and inventory forecast.
• Work with supply chain operations and supply planning to forecast warehouse capacity and ensure gaps are addressed ahead of time to minimize overutilization of warehouse spaces.
• Drive monthly collaborative planning forecasting meetings with key suppliers to share Humacyte forecast and address any gaps as needed to prevent production interruptions due to material shortages.
• Drive monthly collaborative demand meetings with internal customers to drive discussions around future usage and new product introductions
• Continuously identify and develop areas for improvement related to the forecasting process.
• Collaborates in the development of Great Plains Enterprise Resource Planning System (Microsoft Dynamics) process and SOPs as related to demand planning
• Provide input to supply planning organization in developing inventory strategies on existing items, new products, and phase outs.
• Develop SOP’s for Demand Planning processes as required
• Other duties, as assigned

• Able to easily collaborate with a range of internal clients /customers
• Build Consensus
• Possess strong analytical, interpersonal, and business communication skills
• Puts customers first and demonstrating a commitment to service leading to satisfaction for both internal and external customers
• Comfortable facilitating outcomes in meetings with functional leaders
• Works as a team player, and serves as a model by participating in activities that involve cooperating with others

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Bachelor’s degree, required. Master’s degree, preferred
• Minimum of 5 years of related job experience.
• 5+ years of experience in demand planning and forecasting role preferred
• 2 to 3 years of experience in Healthcare / Life Sciences organization preferred
• Demonstrated proficiency in statistics, forecasting, and forecasting methods with an understanding of their financial and operational impacts is required
• Knowledge of Microsoft Dynamics ERP or other software related to demand planning is preferred
• Foundation in analytics & statistics

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Acts as primary IT resource for application implementation and support to ensure alignment with technology industry standards, application technology roadmap, and business needs.
• Research emerging technologies and solutions to support business challenges.
• Engage with internal stakeholders by listening effectively and clarifying information as well as partnering effectively on the design of automated systems.
• Advises and consults senior leadership on costs, benefits, and implementation of technology solutions.
• Recommends changes in process, policies, and standards as they relate to Business Applications
• Exhibits high level of professional flexibility and volunteering innovation and new ideas

• Experience supporting complex business applications and systems in a regulated environment.
• Strong technical knowledge with the ability to convey complex technical concepts in terms that is understandable to the business.
• Understanding of project management concepts in planning and implementing multiple projects in a cross functional environment.
• Strong sense of personal responsibility and accountability for delivering high quality work, both personally, as well as the team level.
• Experience with ERP and Cloud Platform applications.
• Proven experience in shaping and delivering complex new implementations projects related to Enterprise ERP, Finance, Manufacturing, Quality, Sales, Supply Chain, and Order Management.
• Experience with data warehousing, analytics, and visualization
• Strong communication skills (written/verbal) that demonstrate understanding of complex technical details, clarity of thought, and the ability to understand users and their needs.
• Exceptional interpersonal skills, with a demonstrated ability to work collaboratively across the organization

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Bachelor’s Degree in Information Technology or relevant field
• 4+ years of experience in defining and delivering on enterprise applications to support business functions.
• Proven experience managing vendors and contracted support personnel

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Leads daily activities required of vessel production with no supervision
• Leads activities during launches
• Leads projects of medium to complex scope (e.g. operational excellence, safety)
• Trains other team members on major tasks and equipment
• Authors and revises SOPs and BPRs, as appropriate
• Advanced understanding of process automation and electronic business systems
• Recognizes issues and effectively solves atypical process issues
• Leads the collection and tracking of area metrics and process control data
• Leads team effort in the effective and timely completion of root cause investigations and CAPA implementation
• Performs cleaning and preparation of production equipment, and cleaning/disinfecting of production rooms
• Leads the assembly, set-up, and disassembly of production equipment
• Ensures process steps are followed according to defined SOPs and BPRs
• Ensures proper documentation of activities in accordance with cGMPs
• Adheres to the proper handling of chemically hazardous goods
• Supports qualifications and validation activities, as assigned
• Supports coordination of equipment and personnel resources on a daily basis, to ensure production is not impacted
• Completes a variety of atypical assignments, as needed
• Works autonomously and completes work within established standard operating procedures (SOPs) and/or scientific method
• Other duties, as assigned

• Able to troubleshoot mechanical and/or process issues.
• Works within defined processes and methods and may help determine the appropriate approach for new assignments.
• Solid understanding of how related teams coordinate their efforts and resources to achieve objectives
• Works as a team player, and serves as a model by participating in activities that involve cooperating with others
• Applies functional and technical knowledge across a range of processes or operational procedures to deliver high quality work.
• Seeks out additional data from multiple perspectives to understand problems.
• Ability to differentiate between important and less important tasks within own work and act accordingly
• Attempts to solve problems before seeking support

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• High School Diploma or GED, required. Associate or Bachelor’s degree, preferred
• 4+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required
• Demonstrated knowledge of cGMP requirements, required
• Experience executing SOPs and documenting work, required
• Basic mechanical aptitude or knowledge of electrical / mechanical equipment, preferred
• Previous cell culture experience, highly preferred
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Demonstrated competence in clean room environment practices with ability to train others
• Position may require working holidays, weekends and over-time

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Provides quality oversight of GxP (GLP/GCLP/GLP/GVP) processes and functional areas (Clinical Operations, Clinical Development, Regulatory, Nonclinical etc.) both internally and externally
• Proactively identifies the need for and conducts various expert level audits (including internal, clinical sites, CROs, IRBs, partners, etc)
• Provides leadership and collaboration in preparation and support of regulatory GCP/GVP inspections, prepares, and conducts Pre-Approval Inspection (PAI) activities as needed
• Effectively and professionally collaborates with CROs and other external contractors and collaborators, managing the chain of communication related to GCP compliance
• Drafts and revises company SOPs to assess their adequacy and compliance with industry and regulatory requirements
• Attend and actively participates in cross-functional team meetings, providing guidance and leadership to different functional groups, based on interpretation of current regulations to ensure best practices including risk-based approaches
• Escalates issues of critical non-compliance and/or lack of urgency in remediation with recommendations for remedy or mitigation to senior management via the Quality Board
• Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant documents
• Provide and/or assist in periodic GCP training to the internal and external staff as necessary

• Deep and demonstrated knowledge of Good Clinical Practices (GCP)
• Working knowledge of “good practices” (GxP), leading to compliance with regulatory requirements
• Experience auditing clinical study sites and CROs, experience with TMF Audits, and regulatory inspections.
• Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
• Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
• Works as a team player, and serves as a model by participating in activities that involve cooperating with others

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• BS degree in relevant discipline, required
• At least 10 years of direct GCP pharmaceutical/biotechnology experience
• Solid understanding and application of GCP, GLP and ICH E6R2 requirements. Good working knowledge of GVP guidelines
• Ideal candidate will have broad experience in product development, support of clinical operations, field GCP auditing and regulatory inspection support.
• Excellent interpersonal and conflict management skills to assure effective interactions within and across departments
• The ability to simultaneously handle multiple project issues while dealing with time demands, ability to provide a solution-based approach to emerging challenges
• A strong team player is required with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations & business needs

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Partner with Quality, Engineering and Operations groups to always ensure strict compliance with CMMS cGMP/GLP guidelines
• Measure and assist with reporting of KPI metrics daily/weekly by improving processes, helping interpret facts and data, and by making sound recommendations based on quantitative and qualitative date
• Measure and publish facility’s PI metrics to the management team; interpret data, troubleshoot processes and make recommendations based on findings
• Coordinates outside calibration activities with vendors.
• CAPA System: Utilize this Quality system to evaluate identifiable factors to solve problems diverse in scope and implement continuous improvement corrective and preventive actions for system level improvements.
• Change Control System: Identify and initiate changes through collaborative efforts with Quality Assurance and applicable departments in response to deviations, CAPA’s and departmental continuous improvement projects.
• Utilizes multifunctional teams to implement process and continuous improvements within Quality Systems (Deviation, CAPA, CC, SOPs, Risk Analysis, Root Cause Analysis, etc.)
• Support Facility Maintenance, and Metrology in the development and revision of Standard Operating Procedures (SOPs), completion of periodic reviews, and other quality documentation.
• Assist in generation of departmental quality metrics and track the status of active records.
• Other duties, as assigned

• Basic understanding and application of instrument, equipment, calibration, and maintenance of various parameters in manufacturing, utilities, and laboratory environments within a cGMP Biotechnology / Pharmaceutical manufacturing environment.
• Understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios.
• Able to make independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction
• Proven knowledge of a Computerized Maintenance Management System (CMMS)
• Strong organizational and planning skills required
• Excellent interpersonal effectiveness and communication skills (written and oral) are required to interface across management levels and departments
• Works as a team player, and serves as a model by participating in activities that involve cooperating with others

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Associates Degree in Engineering, Life Sciences or other related technical field, required or equivalent military training. Bachelor’s degree, preferred
• 3+ year Data management and documentation, CMMS experience, required
• 5 years of Quality System/Pharmaceutical experience, preferred
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may require working some over-time

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Facilitate negotiations with suppliers, contractors and partners
• Manage the contracting process working closely with the Finance and Regulatory departments
• Provide procurement leadership for all phases of the sourcing process, including project identification and start up, data collection and analysis, option development and recommendation preparation, implementation and supplier management
• Work in conjunction with senior management to seek optimal balance between total product costs/terms, lead time, order minimums, standard packs and other factors while maintaining adequate merchandise quality, quantity and specification requirements
• Develop and manage metrics to track cost savings and cost avoidance, supplier performance via order to actual delivery time, purchase price variance and other critical key performance indicators
• Initiate, develop and prepare Opportunity Analysis for specific spend areas and projects
• Collaborate within the Supply Chain team in handling special buys and large buys by establishing on-going communication on issues such as space requirements, delivery details, and special handling instructions
• Provide all aspects of personnel management for direct reports including: developing strategic staffing plans that align with company and departmental objectives; recruitment of appropriate team members; determining work assignments; performance management; development and coaching of team members; engagement and retention
• Partner with Finance to understand budgets and financial forecast processes to ensure expenses come in on budget
• Develop/revise, implement and maintain processes, templates, reports, and best practices to be used in the purchasing/procurement processes
• Partner with internal stakeholders in the supplier selection and review process by researching market acceptance, price, quality, service, support, and other factors
• Educate Humacyte personnel on supplier, contractor and partner management practices that influence the culture on processes and techniques to maximize vendor performance, and develop roles and responsibilities guidance to drive better pricing and performance
• Ensure Humacyte personnel adhere to Supply Chain Master Data creation and modification processes
• Direct the process for material creations, modifications, and extensions while working in close collaboration with technology transfer team to ensure identified items are available for use on the site
• Develop and implement strategies that achieve the strategic and tactical requirements of Master Data Management at Humacyte
• Enforce policy and procedure to remain compliant with all laws governing the pharmaceutical industry; works closely with the compliance department to ensure adherence to policies
• Ensure established policies, practices and internal controls are adhered to in the sourcing process
• Support business partners by contributing to development and execution of the following:
  • Partner with senior leadership to identify business needs and align strategic sourcing activities to those needs
  • Provide executive updates on strategic plan and key sourcing performance metrics
  • Build and maintain strong, mutually beneficial relationships with key suppliers and business partners
  • Build a network of Strategic Sourcing professionals to enable him/her to become/stay current with the latest category management and sourcing trends and best practices
• Execute or assist with RFP process for strategic purchases
• Interpret and analyze current and past trends in key performance indicators, including areas of COGS, inventory, operating expenses and Capex; identify areas of opportunities and risks and to provide recommendations
• Other duties, as assigned

• Demonstrable background in leadership of procurement ethics
• Formal training in current good manufacturing practices (cGMP) and Sarbanes/Oxley (SOX) requirements
• Build and implement a sourcing and procurement process by establishing procurement policies, guidelines and best practices and driving value and savings on purchases
• Build/implement tools to objectively review suppliers (i) before purchase and (ii) for performance and continued due diligence and supplier compliance after purchase
• Define and track operational reporting and metrics needed to drive improvements and improve efficiency in the sourcing process
• Perform industry benchmarking with respect to pricing, performance, service levels and other measurable standards

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Bachelor's Degree; MBA desirable; C.P.M. or A.P.P. desirable
• 6+ years of relevant experience in purchasing/procurement, preferably in the biotechnology/pharmaceutical industry, with deep understanding of supply chain, technology and marketing sourcing needs
• Experienced with Great Plains, or similar ERP system
• Previous small team management or leadership required
• Proven ability to proactively build positive, collaborative relationships with multiple levels and parties
• Must have knowledge of laws governing pharmaceutical companies contracting with healthcare providers, government groups, and similar individuals/organizations
• Excellent analytic skills; highly proficient in Excel-based modeling

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies
• Please note, Humacyte does not provide sponsorship at this time.**

• Function as FDA point contact
• Lead BLA submission effort across-function
• Serve as regulatory strategist and regulatory project lead for assigned project
• Accountable for establishing regulatory strategy for assigned project in US and global
• Monitor and interpret FDA and other health authorities’ new policies and guidance, and assess the impact on company’s business
• Could function as global regulatory lead 
• Might coach and mentor junior staff supporting the regulatory team
• Other responsibilities assigned when there is a business need

• Recent hand-on experience with leading BLA submission, preferably to FDA/CBER
• Recent experience with developing biologics
• Have demonstrated successful submission and secured approval of BLA/NDA from FDA
• Have functioned as FDA and other health authorities’ point contact
• Have led formal meetings with FDA and other health authorities
• Familiar with FDA content and technical requirement for BLA submission
• Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs
• Competent in leading across-function team and managing timelines
• Able to work under tight timeline and high stress situation

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Requires a Bachelor’s degree, or equivalent on the job experience, plus 4-6 years of experience in project management in a scientific or life sciences industry. 
• Graduate Degree in Life Science is required. Ph.D, MD or Pharm D in Life Science highly preferred
• At least 5 years of regulatory project lead experience is required 

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Support the proper compilation, documentation and archival of regulatory submissions including clinical trial applications; Biologics License (BLA) Applications, Investigational New Drug (IND) applications, Marketing Authorization Approvals (MAAs), and others
• Function as Point Contact for all submissions with external e-Publishing vendor
• Responsible for creating regulatory templates and style guides (Cover letter, General Correspondence letter etc.)
• Format (ToC, hyperlinking etc) and QC regulatory documents
• Track, archive and manage global submission documents
• Monitor and interpret all applicable regulatory requirements, assure technical compliance of submissions 
• Assist regulatory project lead in submissions and interactions with health authorities
• Might be assigned to establish ePublishing platform in future
• Any other responsibilities assigned according to business need

• Competent in eCTD assembling and ePublishing
• Knowledge and hand-on experience on FDA technical requirements for INDs and BLAs
• Expert knowledge on Adobe Writer and MS Word
• Must be able to work under tight timeline
• Ability to work effectively and efficiently handling multiple tasks simultaneously
• Proven project and timeline management skills

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Minimum of 12 years of related job experience.
• Bachelor degree is required, and advanced degree is a plus
• At least 3 years of regulatory operation working experience after graduation
• Knowledge of regulatory requirements in US. Additional regions a plus
• Understanding of eCTD dossier requirements for Biologics License (BLA) Applications, Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND/CTA)

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

• Assist with performing and documenting process development experiments
• Support aseptic sample collection and analysis using cell counters, dissolved gas analyzers, and metabolite analyzers
• Ensure accurate data is acquired for continuous process monitoring
• Ensure unexpected findings and observations during bioprocessing are reported to other PD Associates and management
• Troubleshooting of basic/routine processes/equipment
• Assist in the setup, daily monitoring, and breakdown, of bioreactor experiments
• Support the aseptic compounding and aliquoting of cellular growth medium and buffers
• Assist with the construction and packaging of bioprocessing tubing manifolds
• Report process alarms to Leads or Manager
• Other duties, as assigned

• Knowledge of GMP quality systems
• Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
• Familiarity and understanding of foundational cGMP compliance in the biotech/bioprocessing manufacturing environment
• Knowledge of Code of Federal Regulations 21 CFR 1271, a plus
• Detail-oriented, self-motivated and scientifically driven
• Excellent communication and interpersonal skills
• Demonstrated ability to work in a cross functional team

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• High School Diploma or GED is required, Bachelor's Degree in Biology, Chemistry or other related field is preferred
• At least 1 years of experience with cell culture, cell therapy, bioprocessing, tissue engineering, or regenerative medicine, biotech/pharma, required
• Previous cell culture experience, required
• Previous experience in Process Development, preferred
• Strong background/technique in aseptic processing, preferred
• Bioreactor experience, preferred
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may require working holidays, weekends, etc.

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies
• Please note, Humacyte does not provide sponsorship at this time.**

• Leads and provides oversight for the Validation function within the Commercial Manufacturing organization. This includes managing priorities, workload and schedules for all validation activities.
• In collaboration with Manufacturing Leadership, develops Validation strategy and processes to deliver on both short-term and long-range objectives
• Communicates anticipated or known areas of concern within the validation team and cross-functionally. Provides recommendations for risk mitigation or issue resolution using data and knowledge of validating cGMP systems.
• Works collaboratively with Bioprocessing, Engineering, Automation, Facilities, IT, Supply Chain, Product Development, and Quality (QA/QC) teams to achieve corporate and departmental objectives
• Actively participates in cross-functional team meetings related to changes in processes, process improvements and provides recommendations and direction.
• Manage all aspects of personnel management including staffing strategy, recruitment of appropriate team members, performance management and development of team members; including positive engagement and employee retention activities.
• Works with Manufacturing Leadership to develop and manage annual budget needed to achieve corporate and departmental objectives
• Develops, reviews and/or approves protocols and other sources of information to ensure that validations and procedures are consistent with company policies, current industry requirements, regulatory requirements, and current technology.
• Other duties, as assigned

• Ability to work and lead a team to plan, organize and prioritize work consistent with Company and Department goals
• Demonstrated understanding of facility, utility, computer systems and equipment life cycle management and requalification programs
• Excellent interpersonal, influencing and negotiation skills

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Biochemistry, or related areas, required. Master’s degree, preferred
• 8-10 years of pharmaceutical work experience with at least 2 years managing full-time direct reports
• Experienced, accomplished personnel manager and leader with strong interpersonal, business and communication skills
• Strong understanding of U.S. cGMP, ISO, ICH, and EC compliance requirements
• Experience in qualification of cGMP biopharmaceutical equipment/software systems.
• Experience developing and reviewing validation documents.
• Prior experience with regulatory inspections preferred.

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies
• Please note, Humacyte does not provide sponsorship at this time.**

• Provides quality oversight of GxP (GLP/GCLP/GLP/GVP) processes and functional areas (Clinical Operations, Clinical Development, Regulatory, Nonclinical etc.) both internally and externally
• Proactively identifies the need for and conducts various expert level audits (including internal, clinical sites, CROs, IRBs, partners, etc)
• Provides leadership and collaboration in preparation and support of regulatory GCP/GVP inspections, prepares, and conducts Pre-Approval Inspection (PAI) activities as needed
• Effectively and professionally collaborates with CROs and other external contractors and collaborators, managing the chain of communication related to GCP compliance
• Drafts and revises company SOPs to assess their adequacy and compliance with industry and regulatory requirements
• Attend and actively participates in cross-functional team meetings, providing guidance and leadership to different functional groups, based on interpretation of current regulations to ensure best practices including risk-based approaches
• Escalates issues of critical non-compliance and/or lack of urgency in remediation with recommendations for remedy or mitigation to senior management via the Quality Board
• Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant documents
• Provide and/or assist in periodic GCP training to the internal and external staff as necessary

• Deep and demonstrated knowledge of Good Clinical Practices (GCP)
• Working knowledge of “good practices” (GxP), leading to compliance with regulatory requirements
• Experience auditing clinical study sites and CROs, experience with TMF Audits, and regulatory inspections.
• Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
• Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
• Works as a team player, and serves as a model by participating in activities that involve cooperating with others

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• BS degree in relevant discipline, required
• At least 10 years of direct GCP pharmaceutical/biotechnology experience
• Solid understanding and application of GCP, GLP and ICH E6R2 requirements. Good working knowledge of GVP guidelines
• Ideal candidate will have broad experience in product development, support of clinical operations, field GCP auditing and regulatory inspection support.
• Excellent interpersonal and conflict management skills to assure effective interactions within and across departments
• The ability to simultaneously handle multiple project issues while dealing with time demands, ability to provide a solution-based approach to emerging challenges
• A strong team player is required with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations & business needs

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies
• Please note, Humacyte does not provide sponsorship at this time.**

• Facilitates cross-departmental collaborations on PD-impacting workstreams, including:
  • Metrology and Facilities, regarding equipment maintenance, repair, and timelines
  • Quality Assurance on compliance and audit readiness
  • Supply Chain on Bill of Material creation and upkeep
  • Supply Chain Operations on material limitations and supply risks
  • QC on sampling timelines and batch sampling plans
  • Others, where needed
• Facilitates intra-departmental collaboration within Process Development, including:
  • Coordination with Operations teams on scheduling, deviations, and time-sensitive tasks
  • Coordination with Biomaterials on batch preparation (mesh prep and OCT)
  • Coordination with Engineers on batch-impacting projects
• Monitors and troubleshoots limited/unavailable supplies with PD Team and manages waste across PD by identifying ways to streamline materials/supplies/shipments
• Stays up to date with PD experiments, to coordinate within PD on materials, operations, and schedule as needed.
• Assists with Deviation management and change controls, as necessary
• Organizes and coordinates distribution and storage of datasets for PD including, but not limited to
  • Batch in-process data for in-process data review meetings
  • Storage of batch owners materials including batch summary reports, scanned BPRs, and tracking files
• Coordinates investigations into underperforming batches – reaches out to stakeholders, organizes and documents investigation discussions, lists and follows up with action items assigned
• Serves as a back-up or assists as needed with daily activities required in Process Development Department
• Ensures Humacyte or other required trainings/certifications are up to date for all PD team members
• Other duties, as assigned

• Exceptional communication and organization
• Demonstrated ability to work in a cross functional team
• Expertise in inventory management
• Documentation authorship, review and approval
• Knowledge and experience in Deviation Management and performing Change Controls
• Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
• Knowledge of GMP quality systems
• Familiarity and understanding of foundational and advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
• Detail-oriented, self-motivated and scientifically driven
• Works as a team player and serves as a model by participating in activities that involve cooperating with others

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• High School Diploma or GED, required
• Bachelor’s degree, preferred
• At least 5 years of experience with cell culture, cell therapy, bioprocessing, tissue engineering, or regenerative medicine, biotech/pharma, required
• Background in upstream process development, biotechnology, bioprocessing, cell therapy, chemical engineering, tissue engineering, regenerative medicine and/or cell biology, required
• Experience with inter-departmental coordination or project management, required
• Experience in process development, preferably in early-stage development of biologics, required
• Basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment, highly preferred
• Tissue engineering experience, specifically with synthetic polymer scaffolds, strongly preferred
• Previous cell culture experience, preferred
• Experience supporting pre-clinical or clinical production in a GMP setting, preferred
• Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment, preferred
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may infrequently require working holidays, weekends, etc.

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies
• Please note, Humacyte does not provide sponsorship at this time.**

• Internal and external customers and points of contact include
  • CMS and other payors
  • Lobbyists
  • External, Health Economist(s)
  • Humacyte Leadership Team (HLT)
  • Humacyte Board member(s)
  • Alliance Partners

• Collaborate, support development and refinement of global market access strategy from product development through launch and lifecycle management inclusive of pricing, reimbursement, value proposition, value messaging and payor strategies for all indications.
• Translate global market access strategy to a tactical plans that optimizes pricing and reimbursement in all relevant geographies, domestic and international. Accountable for budget planning and cross-functional integration with medical and brand plans.
• Monitor global payor policy trends and developments to proactively identify needs and actions to support the value proposition of the Humacyte portfolio.
• Direct input to payer national coverage policy and innovative reimbursement programs such as NTAP by supplying and framing clinical and health economic data and through coalition advocacy.
• Ensure integration of market access and payer perspectives (gained via market research or Advisory Boards) into product development plans at all stages of development in close collaboration with clinical, medical, HEOR and and commercial colleagues.
• Develop global pricing strategies and ongoing assessment and adaptation to ensure an optimal balance of revenue, volume, margin and access across geographies.
• Establish best practices and guidance for global pricing and reimbursement ways of working, inclusive of key deliverables, governance, processes, and interaction model across Humacyte, Alliance Partners, and regions/ countries.
• Perform all company business in accordance with regulations and company policies and procedures.

• Demonstrated integrity on work-related compliance considerations and solid ethics
• Strong strategic thinking skills, ability to scenario plan, craft strategic options, prioritize and problem solve
• Proven positive and strong negotiation / influencing skills and the ability to work at a peer-level with experienced technical and commercial experts in other functions
• Has excellent communication skills with the ability to communicate complex information in a convincing way to non-technical audiences
• Displays business acumen to constructively challenge and collaborate with marketing and clinical colleagues
• Excels in a fast-paced, results-driven, highly accountable environment where you can make a clear impact
• Maintains a Humacyte, rather than a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the Company

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled

• Bachelor’s degree required; advanced degree in life sciences, clinical sciences, health economics, or business degree preferred.
• 8-10 years of experience in the pharmaceutical industry / healthcare field including significant experience (6+) in global market access, pricing, reimbursement and value assessment in a broad range of therapy areas including biologics / Rx specialty care products and devices
• Deep knowledge of US health care policy and payment systems, including Medicare and commercial payors, in all sites of service settings (inpatient, outpatient and ASCs). US new product launch experience required.
• Global market access experience inclusive of supporting strategy development and hands-on tactical execution within key geographies including but not limited to US, EU, ROW
• Proficient and knowledgeable about the market access pathways across major geographies and trends in HTA, pricing, and payer innovative access programs (ie value-based payments and risk sharing models)
• Experienced and adept at navigating international, multilingual and cross-functional organizational matrices and work effectively with Alliance Partners, Regions and Country teams
• Proven track record of translating product advantages in the context of market requirements into impactful value stories and successful negotiations with payers and health systems in securing patient access

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies
• Please note, Humacyte does not provide sponsorship at this time.**