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Associate Director, Quality Assurance

1 month ago

Étreux, Hauts-de-France, United States PepGen Full time
About the Role

We are seeking a highly experienced Associate Director, Quality Control to join our team at PepGen. As a key member of our Quality Control department, you will be responsible for leading and managing the QC activities of our pipeline, ensuring compliance with regulatory requirements and company standards.

Key Responsibilities
  • Lead and manage in-process, release, and stability testing at CMOs/CTLs
  • Contribute to the development of control strategies for peptides, oligos, and peptide-oligo conjugates
  • Manage the inventory of qualified reference standards and oversee laboratory investigations
  • Lead the stability design and manage stability programs
  • Coach and mentor junior QC scientists in the group
  • Collaborate with CTLs/CROs/CMOs and other external partners
  • Lead QC-related regulatory reports, submissions, and responses
Requirements
  • Ph.D. in Chemistry or related area and >5 years' experience in quality control or relevant role
  • Proven track record moving projects from early development to commercialization as a QC lead
  • Experience with phase-appropriate method qualification, validation, and transfer
  • HPLC, LC-MS, or LC-MS/MS experience, preferably with synthetic peptides and oligonucleotides
  • Experience using statistical software for setting specifications, stability data trending, and establishment of shelf-life
  • Working knowledge of quality systems and domestic and international regulatory requirements
About the Team

We are a team of passionate and creative scientists committed to analytical development and quality control of innovative EDO platform. We value honest communication and open-mindedness. We are looking to enhance our group with another collaborative team member who shares our values and commitment to making a meaningful difference for patients.