Director, Quality Control

About the role

We are seeking a Director of Quality Control to lead and oversee QC strategy and execution in a fast-paced, research-driven biotech environment.

Responsibilities

• Establish and build QC systems, processes, and infrastructure in a startup environment to support clinical development.
• Build QC team or manage external CDMOs as appropriate; provide vendor or team oversight and manage performance.
• Lead QC strategy for clinical-stage programs, ensuring appropriate testing, release, and stability support.
• Serve as the primary QC interface between internal teams (Analytical Development, QA, CMC) and external CDMOs and testing laboratories.
• Manage method lifecycle activities, including development alignment, qualification/validation, transfer, and lifecycle management at external labs.
• Collaborate with Analytical Development to define and justify specifications, acceptance criteria, and control strategies.
• Ensure GMP-compliant execution of release and stability testing at CDMOs and testing laboratories, including data review, trending, and issue resolution.
• Partner with QA to support batch disposition, investigations (OOS/OOT), deviations, and change controls.
• Support regulatory submissions (IND/IMPD) by contributing to Module 3 and responding to health authority questions as needed.
• Drive continuous improvement of QC systems, processes, and external partnerships.
• Travel to CDMO and testing labs as required to ensure operational excellence.

Requirements

• Strong knowledge of analytical techniques including HPLC/UPLC, LC-MS, peptide mapping, and bioassays.
• Experience with characterization and release testing for peptides, large molecules, and bioconjugates.
• Deep understanding of method development, qualification/validation, and transfer to CDMOs or contract labs.
• Expertise in setting specifications, acceptance criteria, and control strategies for clinical-stage products.
• Familiarity with stability-indicating methods and degradation pathways.
• Working knowledge of GMP requirements, data integrity, and regulatory expectations for QC testing.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Biochemistry, or related field with 10+ years of relevant experience in QC, Analytical Development, or related functions in biotech/pharma.
• Strong experience with peptides, large molecules, and/or bioconjugates.
• Deep understanding of analytical methods (e.g., HPLC/UPLC, LC-MS, bioassays) and method lifecycle management.
• Demonstrated experience setting specifications and developing control strategies for clinical-stage products.
• Proven track record of managing method transfers and working effectively with CDMOs and contract testing laboratories.
• Solid knowledge of GMP requirements, regulatory expectations, and clinical development processes.
• Experience with stability programs, data trending, and interpretation.
• Strong cross-functional leadership and communication skills, with the ability to operate effectively in a startup environment.

Preferred Attributes

• Prior experience in early-stage or startup biotech environments.
• Hands-on experience supporting IND/IMPD filings and health authority interactions.
• Ability to balance strategic thinking with hands-on execution.

Pay

Salary Range: $190,000 to $230,000 (Compensation will be commensurate with experience/expertise/level and could fall outside of the stated range)