Director, Quality Control

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 190,000 - 230,000; Full time

Job summary

Initial Therapeutics, Inc. seeks a Director of Quality Control to lead QC strategy and execution in a fast-paced biotech environment. You will coordinate Analytical Development, QA, and external CDMOs to ensure clinical-stage products are tested, compliant, and safe for use.

You will build and scale QC systems, oversee vendors, manage method lifecycle, and support IND/IMPD submissions while driving continuous improvement in GMP-compliant testing and data integrity.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Biochemistry, or related field with 10+ years of relevant experience in QC/Analytical Development in biotech/pharma.
• Strong experience with peptides, large molecules, and/or bioconjugates.
• Deep understanding of analytical methods (HPLC/UPLC, LC-MS, bioassays) and method lifecycle management.
• Proven experience setting specifications and developing control strategies for clinical-stage products.
• Proven track record of managing method transfers and working effectively with CDMOs.

Responsibilities

• Establish and lead QC systems, processes, and infrastructure to support clinical development.
• Oversee internal QC team or external CDMOs and manage vendor performance.
• Lead QC strategy for clinical-stage programs, ensuring testing, release, and stability support.
• Serve as primary QC interface between internal teams and external labs.
• Manage method lifecycle activities including development, qualification/validation, and transfer.
• Define specifications, acceptance criteria, and control strategies with Analytical Development.
• Ensure GMP-compliant release and stability testing at CDMOs with data review and trend analysis.
• Support batch disposition, investigations (OOS/OOT), deviations, and CAPA.
• Provide technical oversight for stability programs and regulatory submissions (IND/IMPD).
• Drive continuous improvement of QC systems and external partnerships.

Skills

Cross-functional leadership

Strategic thinking

Effective communication

Education

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

Tools

HPLC/UPLC

LC-MS

Peptide mapping

Bioassays

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)