Director, Quality Control

BioSpace; South San Francisco (CA); On-site; USD 190,000 - 230,000; Full time

Job summary

BioSpace seeks a Director of Quality Control to lead QC strategy and execution in a fast-paced biotech setting. You will coordinate between Analytical Development, QA, and external CDMOs to ensure proper testing, release, and safety of clinical-stage products.

The role requires deep expertise in biologics, peptides, and bioconjugates, and hands-on leadership to build scalable QC operations in a startup environment.

Qualifications

• Ph.D./M.S./B.S. in Chemistry, Biochemistry or related field with 10+ years in QC/Analytical Development in biotech/pharma.
• Experience with peptides, large molecules, and bioconjugates.
• Deep understanding of analytical methods (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 with CDMOs and testing laboratories.
• GMP requirements, regulatory expectations, and clinical development processes.
• Experience with stability programs, data trending, and interpretation.
• Strong cross-functional leadership and startup environment adaptability.

Responsibilities

• Establish and build QC systems, processes, and infrastructure in a startup environment.
• Build QC team or manage external CDMOs; provide vendor or team oversight.
• Lead QC strategy for clinical-stage programs and release/stability support.
• Serve as primary QC interface between internal teams and external CDMOs/testing labs.
• Manage method lifecycle activities: development, qualification/validation, transfer, lifecycle management.
• Collaborate with Analytical Development to define specifications, acceptance criteria, and control strategies.
• Ensure GMP-compliant release and stability testing at CDMOs and labs; data review and trend analysis.
• Partner with QA on batch disposition, investigations (OOS/OOT), deviations, CAPA.
• Oversee stability program study design, data interpretation, shelf-life assessments.
• Support IND/IMPD regulatory submissions by contributing to Module 3.
• Drive continuous improvement of QC systems and external partnerships.
• Travel to CDMOs/testing labs as required.

Skills

HPLC/UPLC

LC-MS

Peptide mapping

Bioassays

Method development

Qualification/validation

CDMO transfer

GMP/data integrity

Leadership

Education

Ph.D./M.S./B.S. in Chemistry/Biochemistry or related

Tools

CDMO collaboration tools

Job description

We are seeking a Director of Quality Control to lead and oversee QC strategy and execution in a fast-paced, research-driven biotech environment. This role will serve as the key liaison between JLSa2’s Analytical Development, Quality Assurance, and external CDMOs/testing laboratories to ensure that clinical-stage products are appropriately tested, compliant, phase appropriate, and safe for use. The role will report into the head of Quality. The ideal candidate will bring strong technical expertise in biologics—particularly peptide and bioconjugate modalities—and a deep understanding of analytical development, method transfer, and specification setting.

Key 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.
• Be accountable for technical oversight for stability programs, including study design, data interpretation, and shelf-life assessments.
• 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.
• Trave to CDMO and testing labs as required to ensure operational excellence.

Technical Expertise

• 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.

Leadership & Operational Skills

• Proven ability to lead cross-functional initiatives and influence without direct authority in a matrixed environment.
• 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 simultaneously.
• Demonstrated ability to drive issue resolution, including investigations (OOS/OOT), root cause analysis, and corrective/preventive actions (CAPA).
• Excellent communication skills, with the ability to translate complex technical information to cross-functional 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.

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.

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