Principal, Analytical Product Lead

COMPANY:Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte's 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte's 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The Principal, Analytical Product Lead plays a pivotal role in driving the analytical strategy for Humacyte products. This position requires effective collaboration with multiple departments to ensure alignment with scientific, technical, and quality expectations while meeting regulatory standards and Humacyte milestones. The ideal candidate will oversee the development and implementation of analytical strategies, provide technical support for method troubleshooting, and contribute to regulatory filings and responses.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Oversee the development and implementation of end-to-end Quality Control strategy for Humacyte products.
• Provide technical support for method troubleshooting, OOS management, and investigations.
• Be accountable for reviewing data and troubleshooting analytical testing and methods.
• Contribute to Annual Product Quality Reviews, Regulatory Filings, and responses to Information Requests from Regulatory Agencies.
• Interface with Regulatory agencies, as required, representing Humacyte to health authorities and regulatory inspections in matters relating to QC Operations and Stability Studies.
• Monitor test method execution in QC laboratories to ensure methods are in a continuous state of control.
• Design, support, and manage execution of analytical method validations.
• Manage data review and statistical analysis for analytical methods.
• Provide stability study management including writing stability protocols and reports.
• Lead or serve as a key project team member on large cross functional projects.
• Collaborate with CMC leadership to define the overall analytical strategy and analytical lifecycle management.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree in Microbiology, Biochemistry, Chemistry, Chemical Engineering, Biochemical Engineering, required; advanced degree (Masters or PhD) highly preferred.
• 10+ years relevant working experience, within an established biotechnology organization in analytical development and/or quality control, with experience in cell and gene therapy, vaccines, and/or complex biologics.
• Experience in analytical method development, technical transfer, qualification and validation.
• Experience with authoring regulatory documents and supporting filings (BLA,MAA).
• In-depth technical and regulatory understanding of GMP biologics manufacturing and testing including applicable international regulations/standards (GMP and ICH guidelines) in all phases of product development and commercialization.
• Leadership experience in a matrixed analytical environment.
• Prior experience representing analytical development or QC on cross-functional CMC project teams.
• Experience working within a GMP testing environment.
• Exceptional organizational, communication, leadership, and project management skills.

COMPENSATION & BENEFITS HIGHLIGHTS:

• 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 U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.