Associate Director, Quality Control
On-siteWaltham, Massachusetts, United States
Job Summary
Manage phase-appropriate stability, specification, and reference standard programs while serving as the QC point of contact for CDMOs and contract testing laboratories. Ensure external partners perform release, stability, and in-process testing in accordance with GMP requirements and regulatory expectations. Generate Certificate of Analyses for intermediate material and drug substance/product, monitor stability studies, and chair review board meetings for shelf-life assignments. Provide oversight for OOS/OOT investigations, deviations, CAPAs, and change control, while collaborating on analytical method transfer, qualification, and validation. Support authoring of Module 3 regulatory submissions and establish lean QC systems and SOPs. This role is based in Waltham, MA, requiring a minimum of 10 years in biologics QC with deep expertise in GMP and ICH guidelines.
Required Qualifications
- B.S. or M.S. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
- Minimum 10 years of industry experience in biologics analytical development and QC
- Deep expertise in method qualification, validation, and lifecycle management
- Significant experience overseeing QC activities at CDMOs/CTLs
- Strong understanding of GMP, data integrity principles, and ICH analytical guidelines (Q2, Q5, Q6, Q1E)
- Experience supporting Module 3 sections of regulatory submissions and interacting with health authorities
- Hands on experience using Microsoft Office, Veeva Vault QualityDoc, LIMS, and Statistical software such as GraphPad Prism, JMP
- Demonstrated ability to lead QC operations in a small or virtual biotech environment
- Strong communication, leadership, and cross-functional collaboration skills
- Experience in biotech
- This role is based in Waltham, MA
Desired Qualifications
- Experience with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus
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