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Director, Analytical Product Lead

4 months ago

Durham, United States HUMACYTE GLOBAL INC Full time
Job DescriptionJob Description

JOB SUMMARY:

The Director, 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 or quality control, with experience in cell and gene therapy/vaccines/complex biologics, etc
  • 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

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.