Jobs in Waltham, MA

About the role

We are seeking an experienced Associate Director of Quality Control (QC) to lead QC operations across the company’s biologics pipeline. You will report directly to the head of QC and will serve as key contributor in overseeing day-to-day QC activities and analytical testing at CDMOs and contract testing laboratories (CTLs). This role is based in Waltham, MA and you must have experience in biotech.

What you'll bring

• 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 with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus.

Benefits