Quality Control (QC) Scientist – Peptide API & Development Site
Job Location:
Menlo Park, CA - USA
Yearly Salary:
Posted on:
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Job Summary
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. No two people are the same so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions were making better health outcomes easier to achieve.
Hims & Hers is a public company traded on the NYSE under the ticker symbol HIMS. To learn more about the brand and offerings you can visit and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: 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. 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. 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. Bachelors degree or higher in Chemistry Biochemistry Analytical Chemistry Pharmaceutical Sciences Microbiology or related field. 37 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. Core Skills & Traits 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. Working Environment Fast-paced startup environment with evolving systems and priorities. 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. 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 We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at 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. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: ICYou Will:
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About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
