Quality Control (QC) Scientist – Peptide API & Development Site

hims & hers
Menlo Park
Workplace: OnsiteFull timeUSD 100,000 - 120,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 3+ yearsEducation: bachelorsSkills: ["Analytical rigor","Data integrity","Investigative problem-solving","Hands-on execution","Cross-functional collaboration"]

Own analytical QC oversight for a peptide-focused GMP API manufacturing and sterile peptide development site. Develop and maintain specifications, analytical methods, and in-process control strategies; plan and execute method qualification/validation under ICH/USP expectations. Lead OOS/OOT and data integrity investigations, manage contract testing labs, and support batch disposition, tech transfer (503A/503B), and inspection-ready documentation and audits.

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FursaFursa
hims & hers
hims & hers
1 month ago

Quality Control (QC) Scientist – Peptide API & Development Site

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Source: Company careers pageValidated by: Fursa AI
Last checked: 6 hours agoStatus: Live

Job Summary

Own analytical QC oversight for a peptide-focused GMP API manufacturing and sterile peptide development site. Develop and maintain specifications, analytical methods, and in-process control strategies; plan and execute method qualification/validation under ICH/USP expectations. Lead OOS/OOT and data integrity investigations, manage contract testing labs, and support batch disposition, tech transfer (503A/503B), and inspection-ready documentation and audits.
Location: Menlo Park
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Own QC analytical oversight across peptide API manufacturing and sterile formulation development, 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 and execute analytical method qualification and validation activities in accordance with ICH and USP expectations.
  • •Lead and document OOS/OOT and other laboratory investigations, identifying root cause and driving corrective/preventive actions.
  • •Manage contract testing laboratory relationships (including microbiology/sterility testing and specialized analytics) and support batch disposition and inspection readiness via audit-ready records and participation in audits.

Pay and Benefits

Salary: USD 100,000 - 120,000 annually
Equity and Bonus:Equity
Perks:Paid LeaveHealth InsuranceDentalVisionParental Leave401kEsppMeal AllowanceRemote Work

Key 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 peptide analytical techniques (e.g., HPLC/UPLC and mass spectrometry) and familiarity with microbiological/sterility testing (plus).
Experience:3+ yearsPharmaceuticalBiotechAPI manufacturingSterile manufacturingGMPPeptide development
Education:Bachelor's in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Microbiology, or related field
Skills:Analytical rigorData integrityInvestigative problem-solvingHands-on executionCross-functional collaboration
Tech Stack:ICH Q721 CFR 210/211USPGood Documentation Practices503A503BHPLC/UPLCMass spectrometryIQ/OQ/PQOOS/OOT

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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