QC Scientist: Peptide API & Development

Hims; Menlo Park (CA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO & company holidays

Comprehensive health benefits

401k with employer matching

Employee Stock Purchase Program

Offsite team retreats

Job summary

Hims & Hers & Hers is seeking a hands-on QC Scientist to own analytical oversight for peptide API manufacturing and sterile formulation development. You will qualify methods, lead investigations, and manage outsourced testing to ensure compliant, inspection-ready batches.

The role requires a strong analytical background, GMP judgment, and collaboration with Quality, Operations, and Technical teams to meet timelines in a fast-paced startup environment.

Qualifications

• Bachelor’s degree 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) 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.

Responsibilities

• Own QC analytical oversight across 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 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 with microbiology and specialized analytical partners.
• Support timely batch disposition through review of analytical data packages and release testing results.
• Generate and support analytical data packages required for 503A/503B tech transfer and 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 calibration/maintenance programs.
• Support inspection readiness by maintaining audit-ready laboratory records and participating in audits.

Skills

Analytical chemistry

cGMP knowledge

Data integrity

OOS/OOT investigations

Lab execution

Cross-functional collaboration

Startup/early-stage experience

Education

Bachelor’s degree in Chemistry/Biochemical/Pharmaceutical sciences

Tools

HPLC/UPLC

Mass spectrometry

Analytical lab instruments (IQ/OQ/PQ)

Job description

Hims & Hers & Hers is seeking a hands-on QC Scientist to own analytical oversight for peptide API manufacturing and sterile formulation development. You will qualify methods, lead investigations, and manage outsourced testing to ensure compliant, inspection-ready batches.

The role requires a strong analytical background, GMP judgment, and collaboration with Quality, Operations, and Technical teams to meet timelines in a fast-paced startup environment.