Quality Control (QC) Scientist (Pharmaceuticals)

TL;DR

Quality Control (QC) Scientist (Pharmaceuticals): Owning analytical Quality oversight for a peptide-focused API manufacturing site and sterile drug product development with an accent on method qualification, batch disposition, and GMP compliance. Focus on leading laboratory investigations (OOS/OOT), managing contract testing labs, and ensuring data integrity in a build-as-you-go startup environment.

Location: On-site in Menlo Park, California

Salary: $100K – $120K

Company

Leading health and wellness platform redefining healthcare through personalized, affordable, and accessible care.

What you will do

• Own QC analytical oversight for peptide API manufacturing and sterile formulation development programs.
• Develop, review, and maintain specifications, analytical test methods, and in-process control strategies.
• Plan and execute analytical method qualification and validation in accordance with ICH and USP expectations.
• Lead and document OOS/OOT and other laboratory investigations, identifying root causes and driving CAPAs.
• Manage contract testing laboratory relationships for microbiology and specialized analytical partners.
• Support timely batch disposition through review of analytical data packages and author relevant SOPs and protocols.

Requirements

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, Microbiology, or a 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 (ICH Q7, 21 CFR 210/211, and USP).
• Must be based in Menlo Park, California for on-site work.

Nice to have

• Experience with analytical techniques for peptides such as HPLC/UPLC and mass spectrometry.
• Familiarity with microbiological and sterility-related testing.
• Experience working in a startup or early-stage site environment.

Culture & Benefits

• Competitive salary and equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental, vision, and parental leave.
• 401k with employer matching and Employee Stock Purchase Program (ESPP).
• Offsite team retreats.