Quality Control (QC) Scientist - Peptide API & Development Site
Job description
Quality Control (QC) Scientist - Peptide API & Development Site at hims-and-hers.
About the role
This position manages analytical quality oversight for a peptide API manufacturing facility that also handles early-phase drug product development. You will serve as the primary analytical lead, ensuring that all testing, data generation, and batch disposition meet strict compliance and inspection-ready standards. This role requires a hands-on approach to building laboratory processes and supporting two parallel programs focused on GMP peptide API production and sterile formulation.
Key facts
What you'll do
- Oversee QC analytical activities for peptide API manufacturing and sterile formulation, including release, stability, and in-process testing.
- Create and manage analytical test methods, specifications, and control strategies.
- Execute and supervise method qualification and validation according to USP and ICH standards.
- Manage laboratory investigations for OOS/OOT results, identifying root causes and implementing corrective actions.
- Ensure laboratory data integrity and adherence to Good Documentation Practices.
- Coordinate with contract testing labs for microbiology and specialized analytical services, including sample management and result review.
- Review analytical data packages to support batch release and tech transfer for 503A/503B programs.
- Author and update SOPs, technical reports, and protocols.
- Partner with engineering, manufacturing, and chemistry teams to align analytical tasks with project timelines.
- Support the qualification, calibration, and maintenance of laboratory instrumentation.
- Maintain audit-ready records to ensure inspection readiness.
Requirements
- Bachelor degree or higher in Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- 3 to 7+ years of experience in QC or analytical laboratories within biotech, pharmaceutical, sterile manufacturing, or API settings.
- Proven experience with OOS/OOT investigations, data integrity, and analytical method validation.
- Practical knowledge of cGMP, 21 CFR 210/211, and ICH Q7 guidelines.
Nice to have
- Experience with peptide-specific analytical techniques such as UPLC, HPLC, and mass spectrometry.
- Background in microbiological or sterility testing and managing contract testing partnerships.
- Previous experience working in a startup or early-stage manufacturing site.
Skills & tools
- Analytical method development and qualification
- Laboratory investigation and root cause analysis
- GMP compliance and documentation
- Cross-functional project coordination
- Instrument qualification (IQ/OQ/PQ)
Practical notes
Benefits include unlimited PTO, quarterly mental health days, 401k with matching, an Employee Stock Purchase Program, and comprehensive health insurance. Hims & Hers provides reasonable accommodations for qualified individuals with disabilities; requests can be directed to accommodations@forhims.com. The company adheres to all fair chance ordinances regarding employment records.