Quality Control (QC) Scientist – Peptide API & Development Site
About The Position
Hims & Hers is seeking a hands-on, startup-minded Quality Control (QC) Scientist to own analytical Quality oversight for a peptide-focused API manufacturing site with early-phase drug product development capabilities. This role supports two parallel programs for GMP peptide API manufacturing and sterile peptide formulation and development. This role also fills the dedicated analytical/QC function that ensures batches and data are generated, tested, and dispositioned to a compliant, inspection-ready standard. The ideal candidate brings strong analytical fundamentals, practical GMP judgment, and the ability to operate in a build-as-you-go setting. This individual is comfortable qualifying methods, writing specifications, leading laboratory investigations, and managing outsourced testing, while partnering closely with Quality, Operations, and Technical teams to keep tech transfer and batch disposition timelines on track.
Requirements
- Bachelor’s degree or higher in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Microbiology, or related field.
- 3–7+ years of QC/analytical laboratory experience in pharmaceutical, biotech, API, or sterile manufacturing environments.
- Hands-on experience with analytical method qualification/validation, OOS/OOT investigations, and laboratory data integrity.
- Working knowledge of cGMP requirements, including ICH Q7, 21 CFR 210/211, and USP laboratory control expectations.
- Experience with analytical techniques commonly used for peptides (e.g., HPLC/UPLC, mass spectrometry, and related methods) preferred.
- Familiarity with microbiological and sterility-related testing and oversight of outsourced/contract testing is a plus.
- Startup or early-stage site experience is a plus.
- Analytical Rigor: Brings sound scientific judgment to methods, specifications, and data interpretation.
- Data Integrity Focus: Maintains accurate, complete, and traceable laboratory records at all times.
- Investigative Problem-Solving: Drives OOS/OOT and laboratory investigations to well-reasoned, defensible conclusions.
- Hands-On Execution: Comfortable working in the lab, reviewing data, and resolving issues directly.
- Cross-Functional Collaboration: Works effectively with Quality, Operations, Technical Development, and external partners.
- Adaptability: Thrives in a fast-paced, build-as-you-go environment with evolving priorities.
Nice To Haves
- Familiarity with microbiological and sterility-related testing and oversight of outsourced/contract testing is a plus.
- Startup or early-stage site experience is a plus.
Responsibilities
- Own QC analytical oversight across both the peptide API manufacturing and sterile formulation development programs, including in-process, release, and stability-related testing as applicable.
- Develop, review, and maintain specifications, analytical test methods, and in-process control strategies for API synthesis and sterile drug product development.
- Plan, execute, and oversee analytical method qualification and validation activities in accordance with ICH and compendial (USP) expectations.
- Lead and document OOS/OOT and other laboratory investigations, identifying root cause and driving appropriate corrective and preventive actions.
- Provide oversight of laboratory data integrity, ensuring compliance with Good Documentation Practices and applicable data governance expectations.
- Manage contract testing laboratory relationships to include microbiology (e.g., bioburden, endotoxin, sterility) and specialized analytical partners — coordinating sample submission, reviewing results, and ensuring testing is performed to agreed specifications.
- Support timely batch disposition through review of analytical data packages and release testing results, escalating issues to the Quality Manager as appropriate.
- Generate and support analytical data packages required for 503A/503B tech transfer and associated comparability assessments.
- Author and review analytical SOPs, protocols, test methods, specifications, and reports.
- Partner with Formulation, Process Chemistry, Manufacturing, and Engineering teams to align analytical requirements with development and manufacturing timelines.
- Support qualification of laboratory equipment and instrumentation (IQ/OQ/PQ) and associated calibration and maintenance programs.
- Support inspection readiness by maintaining audit-ready laboratory records and participating in internal and external audits.
Benefits
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
