Manager, Quality Control - Analytical
About The Position
The Manager, Quality Control (QC) - Analytical is responsible for leading and overseeing the analytical testing program supporting both clinical and commercial drug substance (DS) and drug product (DP) manufacturing in a GMP-regulated facility and registered under the Federal Select Agent Program (FSAP). This role ensures compliant, secure, and timely laboratory testing aligned with global regulatory standards while maintaining strict adherence to select agent and toxin regulations. This position combines leadership, technical expertise, regulatory compliance, and biosecurity oversight to support product release, stability, method lifecycle management, and ensure laboratory readiness for inspections. Works with key laboratory personnel and personnel from other functions, including Quality Assurance, Manufacturing, Supply Chain, and external CMOs and contract testing sites.
Requirements
- Bachelor’s degree & 10+ years’ directly related experience.
- 3-5 years’ management experience.
Nice To Haves
- Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline.
- Master’s of Science or Ph.D. in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline.
- Direct experience working in a BSL-2/BSL-3 lab.
- Experience with a range of biological and physio-chemical methods.
- Experience with regulatory inspections (FDA, EMA, CDC/APHIS).
Responsibilities
- Lead QC analytical testing activities supporting clinical and commercial DS and DP manufacturing, including: in-process testing; release and stability testing; and raw material and excipient testing.
- Ensure alignment of laboratory capacity and scheduling with manufacturing timelines and supply chain demands.
- Oversee the execution of analytical testing for drug substance and drug product.
- Drive on-time batch disposition for both clinical and commercial products.
- Maintain laboratory practices consistent with biosafety (BSL) and biosecurity requirements, including chain-of-custody and material accountability.
- Partner with the Responsible Official (RO) and biosafety teams to ensure inspection readiness for CDC/APHIS/FSAP audits.
- Oversee training and qualification of staff handling select agents.
- Review and approve test results and certificates of analysis (CoA); deviations, OOS/OOT investigations, and CAPAs; stability protocols and reports.
- Serve as key SME during regulatory inspections (FDA, EMA, CDC/APHIS).
- Provide oversight of analytical methods used for DS and DP.
- Lead method validation, verification, transfer, and lifecycle management across clinical and commercial phases.
- Support analytical investigations related to process deviations, product quality issues, and stability trends.
- Lead and develop a team of QC supervisors, analysts, and specialists in a regulated and high-containment environment.
- Ensure personnel are fully trained and qualified in cGMP practices, analytical techniques, and biosafety and biosecurity practices.
- Promote a culture of safety, accountability, compliance, and operational excellence.
- Drive improvements in laboratory efficiency and turnaround times; method robustness and lifecycle management; and error reduction and right-first-time performance.
- Track and improve key performance metrics (KPIs).
- Ensure timely execution of QC deliverables to support release timelines.
Benefits
- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
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What This Job Offers
Job Type
Full-time
Career Level
Manager
