Hims AND Hers

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

Menlo Park, California · Full-time

Sponsorship not specifiedDetected 5 days ago

GMPMass SpectrometryCollaborationProblem SolvingAdaptability

About the role

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.
Plan, execute, and oversee analytical method qualification and validation activities in accordance with ICH and compendial (USP) expectations.
Provide oversight of laboratory data integrity, ensuring compliance with Good Documentation Practices and applicable data governance expectations.

Significant time spent in the QC/analytical laboratory and in support of development and manufacturing activities.
Regular interaction with manufacturing, laboratory, development, and contract testing partners.
May require flexibility in working hours to support startup, validation, testing, and critical operational activities.
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.
Support timely batch disposition through review of analytical data packages and release testing results, escalating issues to the Quality Manager as appropriate.
Support inspection readiness by maintaining audit-ready laboratory records and participating in internal and external audits.
Partner with Formulation, Process Chemistry, Manufacturing, and Engineering teams to align analytical requirements with development and manufacturing timelines.
No two people are the same, so we provide access to personalized care designed for results.

Generate and support analytical data packages required for 503A/503B tech transfer and associated comparability assessments.
Bachelor's degree or higher in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Microbiology, or related field.
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.

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
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.
Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health.
We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery.
By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.
For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals.

We are 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.

If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation.
Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation.

This listing is sourced directly from Hims AND Hers's careers page and normalized into a canonical job model.