Senior Formulation Scientist, Sterile & Peptide Product Development

Senior Formulation Scientist

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.

• 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.

• 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/finish considerations, and container-closure selection.
• Strong understanding of peptide-specific degradation pathways and stability-indicating analytical methods.
• Experience designing and executing stability studies in accordance with ICH Q1A(R2)/Q5C and USP/FDA 503B requirements.
• Proficiency in analytical data interpretation (UPLC/HPLC, mass spectrometry, impurity profiling, and related peptide characterization methods).
• Experience with formulation scale-up and technology transfer within CGMP environments.
• Excellent technical writing, documentation, and cross-functional communication skills.

• Experience evaluating third-party API/BUD data packages and providing technical recommendations as part of make-vs.
  
  -buy sourcing decisions.
• Familiarity with long-acting injectable or novel peptide delivery technologies.
• Experience with regulatory documentation and submissions (IND/NDA or 503B filings).
• Prior leadership or mentorship experience within a formulation or analytical team.
• Experience managing multi-site technology transfer (e.g., coordinating between development and manufacturing facilities).

• Competitive salary &…