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About the Role

Lead and oversee Quality Control (QC) strategy and execution in a fast-paced, research-driven biotech environment. Serve as the key liaison between Analytical Development, Quality Assurance, and external CDMOs/testing laboratories to ensure products are appropriately tested, compliant, phase-appropriate, and safe. Report into the head of Quality.

Responsibilities

• Establish and build QC systems, processes, and infrastructure to support clinical development.
• Build QC team or manage external CDMOs, providing oversight and managing performance.
• Lead QC strategy for clinical-stage programs, ensuring appropriate testing, release, and stability support.
• Serve as the primary QC interface between internal teams and external CDMOs/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.
• Partner with QA to support batch disposition, investigations, deviations, and change controls.
• Be accountable for technical oversight for stability programs.
• Support regulatory submissions by contributing to Module 3 and responding to health authority questions.
• Drive continuous improvement of QC systems, processes, and external partnerships.
• Travel to CDMO and testing labs as required.

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.
• Proven ability to lead cross-functional initiatives and influence without direct authority.
• Experience building and scaling QC operations, systems, and external partnerships in a startup or growth-stage company.
• Strong project management skills, with the ability to manage timelines, priorities, and multiple external vendors.
• Demonstrated ability to drive issue resolution, including investigations, root cause analysis, and CAPA.
• Excellent communication skills, with the ability to translate complex technical information to stakeholders and leadership.
• Strategic thinker with a hands-on, execution-focused mindset.
• Ability to operate effectively in a fast-paced, resource-limited environment with evolving priorities.
• 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 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.
• 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.

Skills

• HPLC/UPLC
• LC-MS
• Peptide mapping
• Bioassays
• Method development
• Method qualification
• Method validation
• Method transfer
• Specification setting
• Control strategies
• Stability programs
• GMP
• Data integrity
• Regulatory expectations
• Project management
• Issue resolution
• Root cause analysis
• CAPA
• Communication skills
• Strategic thinking
• Hands-on execution

Experience Level

• 10+ years of relevant experience

Education Level

• Ph.D.
• M.S.
• B.S. in Chemistry, Biochemistry, or related field

Salary/Compensations

• $190,000 to $230,000