Senior Formulation Scientist Sterile Peptide Product positions focus on delivering results in their domain. This page aggregates open Senior Formulation Scientist Sterile Peptide Product roles and what employers typically expect.
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, we’re 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 hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . 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. ABOUT THE ROLE: We're looking for a Senior Formulation Scientist to join our Sterile Product Development (SPD) team, supporting the development and optimization of both sterile injectable products and peptide-based therapeutics. In this role, you'll lead formulation strategy and process development across a diverse product portfolio, supporting programs from early feasibility through commercial scale-up and lifecycle management. You'll bring deep technical expertise in sterile injectable and peptide formulation development, working cross-functionally with Manufacturing Sciences & Technology (MS&T), Quality, and Regulatory teams to design robust, scalable formulations that meet CGMP and FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. YOU WILL: - Lead formulation and process development for sterile injectable and peptide-based products, including solutions, suspensions, and long-acting injectable formats. - Design and execute pre-formulation, excipient compatibility, and forced-degradation studies specific to peptide stability, including oxidation, deamidation, aggregation, and hydrolysis pathways. - Develop and optimize stability programs aligned with ICH Q1A(R2) and Q5C, including BUD (beyond-use date) justification for compounded and sterile products. - Provide technical input into peptide API selection, characterization, and make-vs.-buy evaluations in partnership with cross-functional stakeholders. - Design lab- and pilot-scale studies to assess formulation feasibility, freeze-thaw stability, container-closure compatibility, and process robustness. - Author and review technical reports, stability protocols, and formulation development summaries to support regulatory filings and internal decision-making. - Partner with MS&T, Quality, and Operations to ensure smooth technology transfer of sterile and peptide formulations from lab to commercial manufacturing across sites. - Support OOS/OOT investigations and CAPA implementation related to sterile and peptide product stability and quality. - Provide scientific mentorship to formulation scientists and technicians, and contribute to SOP development and gap analyses (e.g., ICH stability guideline alignment). - Stay current on peptide delivery technologies, degradation science, and analytical methods, and evaluate new technologies for lifecycle management. YOU HAVE: - Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field with 6–8+ years of industry experience, or B.S./M.S. with 8–10+ years of experience in sterile injectable product development, including direct peptide formulation work. - Hands-on experience formulating peptide therapeutics for parenteral administration (solutions, suspensions, or lyophilized products). - Demonstrated experience developing sterile injectable (parenteral) drug products, with direct involvement in formulation design, fill/fin…