Director, Quality Control

Redwood City, CA /
Quality /
/ Hybrid
Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.

The Position
Quality Control Director is a critical leadership position with responsibility for designing, building and maintaining the company’s QC systems and organization. The position oversees QC activities at external testing facilities (CMOs and contract testing labs), as well as in-house operations supporting Bolt’s clinical development programs. These activities include method and equipment validation, management of specifications and stability programs, and product quality monitoring. This individual will be responsible for managing growth as our pipeline expands.  
Key Responsibilities
·        Hiring and management of QC personnel 
·        Design and implementation of Bolt QC strategies and procedures 
·        Generation, review and approval of SOP’s, protocols, and reports
·        Generation, review and approval of product release and stability specifications 
·        Participation in method transfer, validation, and troubleshooting in conjunction with Analytical Development 
·        Review of release and stability data 
·        Lead, review and/or approve investigations of OOS/OOT, deviations and excursions and CAPAs 
·        Management of stability program and generate expiry establishment and extension documentation  
·        Management of the pre-clinical, in-house and cGMP reference standard programs 
·        Represent Quality Control at internal, external and partner technical meetings and audits 
·        Participate in internal and/or external audits as necessary 
·        Author, review and/or approve portions of the CMC Regulatory documents 
·        Some travel - required, including domestic and international (10-20%) 
·        BA, BS, and/or MS in analytical chemistry, biochemistry, biotechnology or chemistry with a minimum of 12 years of industry experience preferred
·        Experience managing scientists in a clinical cGMP/cGLP 
·        Experience with Word, Excel, PowerPoint, and data analysis tools 
·        Familiarity and experience with ICH guidelines on analytical method transfer, validation, and stability 
·        Familiarity and experience with pharmacopeia methodology 
·        Familiarity and experience with cGMP/cGLP 
·        Proficient in biotechnology related technologies utilized for routine Quality Control analysis 
·        Good technical writing skills  
·        Excellent communication, organizational and collaboration skills 
·        Experience with regulatory filings required  
·        Experience managing CMO/CTL’s required 
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
Bolt Biotherapeutics requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Bolt will consider requests for Reasonable Accommodations.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.