Director of QC & Biologics Testing Strategy

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

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.