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Hims & Hers, a NYSE-traded health and wellness platform, is seeking a Senior Formulation Scientist to join the Sterile Product Development (SPD) team. This role focuses on developing and optimizing sterile injectable products and peptide-based therapeutics, from early feasibility through commercial scale-up and lifecycle management.
Key responsibilities include leading formulation and process development for sterile injectables and peptide products (solutions, suspensions, long-acting formats); designing pre-formulation and forced-degradation studies addressing peptide-specific stability challenges (oxidation, deamidation, aggregation, hydrolysis); developing stability programs aligned with ICH Q1A(R2) and Q5C guidelines; and providing technical input on peptide API selection and make-vs.-buy evaluations. You will design lab and pilot-scale feasibility studies, author technical reports and regulatory documentation, and partner with Manufacturing Sciences & Technology, Quality, and Operations teams to ensure smooth technology transfer from lab to commercial manufacturing.
Additional responsibilities include supporting out-of-specification investigations and CAPA implementation, mentoring junior formulation scientists, contributing to SOP development, and staying current on peptide delivery technologies and analytical methods.
Required qualifications: Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field with 6–8+ years of industry experience (or B.S./M.S. with 8–10+ years). Must have hands-on experience formulating peptide therapeutics for parenteral administration and demonstrated expertise in sterile injectable product development, including formulation design, fill/finish, and container-closure selection. Strong understanding of peptide degradation pathways, stability-indicating analytical methods (UPLC/HPLC, mass spectrometry), and ICH/USP/FDA 503B requirements. Experience with formulation scale-up and CGMP technology transfer required. Excellent technical writing and cross-functional communication skills essential.
Preferred: experience with third-party API/BUD data evaluation, long-acting injectables or novel peptide delivery technologies, regulatory submissions (IND/NDA/503B), prior leadership/mentorship experience, and multi-site technology transfer coordination.
