Vir Biotechnology
Senior Manager, Quality Control
San Francisco, California, United States · Senior · Full-time
No sponsorship$143k-$199kDetected 54 days ago
Product ManagementLogisticsHRIntellectual PropertyGMPFDA RegulatoryAnimal StudiesCollaboration
About the role
- This role ensures the timely and compliant delivery of QC activities, including release and stability testing, method lifecycle management, and vendor oversight.
- This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.
Responsibilities
- Lead QC activities across the product lifecycle (Phase 1 through commercial) for designated programs, ensuring effective implementation of phase-appropriate control strategies.
- Support development and refinement of QC strategies, including methods, specifications, and testing approaches, in collaboration with Analytical Development and QC leadership.
- Drive consistent execution and harmonization of QC methods, specifications, and practices across programs and external partners.
- Identify, assess, and escalate risks to QC performance, supply continuity, and compliance, and implement mitigation plans with cross-functional stakeholders.
- Manage day-to-day execution of QC operations to ensure timely, compliant testing for clinical and commercial programs.
- support CoA generation.
- Lead execution of QC GMP processes (deviations, OOS/OOT, change controls, investigations) in collaboration with QA.
- Manage vendor performance and execution, including CTL/CDMO oversight and routine operational interactions.
- Coordinate and oversee release and stability testing (including CDMOs/CTLs), including review of analytical data, batch records, and supporting documentation; support CoA generation.
Requirements
- Technical expertise in a wide range of analytical methods for release and stability testing of monoclonal antibodies
- Strong scientific background in Quality Control and/or assay development in biotech industry with strong knowledge of cGMP/ICH/FDA/EMA regulations
- Expertise with analytical test method optimization, validation, and transfer as well as working with contract organizations
Nice to have
- BA/BS with 10 + years experience, MA/MS/MBA with 8+ years experience in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering or a related discipline is preferred
Compensation
- The expected salary range for this position is $142,500 to $199,000 per year.
Company info
- The expected salary range for this position is $142,500 to $199,000 per year.
- Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
- Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications.
- All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.
- Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
- All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications.
- Employment decisions are made without regard to any legally protected characteristics.
- This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
- Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
- Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology.
- Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes.
- We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
- For hires based in the United States, Vir Biotechnology, participates in E-Verify.
Visa & Work Authorization
- Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Apply directly at Vir Biotechnology →Create a free account for alerts like thisView Vir Biotechnology immigration profile
This listing is sourced directly from Vir Biotechnology's careers page and normalized into a canonical job model.