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Operations Engineer/ Production Scientist - Peptide Manufacturing

hims & hers - Menlo Park, CA, United States - In-office - posted 2026-09-10

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Hims & Hers, a public healthcare platform (NYSE: HIMS), is seeking an Operations Engineer / Production Scientist to support peptide manufacturing at their Menlo Park facility. This role serves as a technical process owner on the manufacturing floor, with primary focus on Solid-Phase Peptide Synthesis (SPPS), synthesis, cleavage, purification, and lyophilization. You will monitor, analyze, troubleshoot, and continuously improve peptide manufacturing processes. Working closely with Manufacturing, Quality, and Engineering teams, you'll drive improvements in yield and throughput, reduce process variability, support robust GMP operations, and enable data-driven decision-making across the manufacturing process. Key responsibilities include: - Serve as technical process owner for peptide manufacturing operations (SPPS, purification, lyophilization) - Support manufacturing teams during batch execution with real-time technical troubleshooting - Monitor critical process parameters and KPIs across peptide manufacturing - Collect, analyze, and trend manufacturing data to identify variability, yield losses, and improvement opportunities - Develop and maintain manufacturing dashboards tracking yield, cycle time, solvent usage, throughput, batch success rate, and right-first-time metrics - Evaluate coupling efficiency, resin performance, deprotection efficiency, and impurity formation trends - Identify and implement improvements to reaction conditions, cycle parameters, and process controls - Lead initiatives to improve product yield, throughput, cycle time, OEE, and process robustness - Apply Lean Manufacturing, Six Sigma, statistical analysis, and structured root cause analysis tools - Lead or support investigations into process excursions, yield losses, deviations, and equipment issues using Fishbone Analysis, 5 Why Analysis, FMEA, and SPC - Author and revise SOPs, Master Batch Records, process descriptions, and technical reports - Support deviation investigations, CAPAs, change controls, risk assessments, process validation, and continued process verification - Ensure technical documentation is accurate, complete, and cGMP-compliant - Partner cross-functionally with Operations, Engineering, Quality, Supply Chain, and site leadership - Support implementation of new equipment, technologies, and manufacturing systems - Participate in production planning, operational excellence reviews, and process improvement meetings - Provide technical mentoring and training to manufacturing personnel The ideal candidate brings strong peptide manufacturing or API process experience, a hands-on manufacturing mindset, and the ability to use process data and continuous improvement tools to enhance manufacturing performance. REQUIREMENTS: - Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or related field - 3–7 years of experience in pharmaceutical, biotechnology, peptide manufacturing, API manufacturing, or related chemical processing environments - Hands-on experience supporting GMP manufacturing operations, investigations, and process validation activities - Direct experience with Solid-Phase Peptide Synthesis - Experience analyzing manufacturing process data and implementing process improvements - Strong technical troubleshooting skills with ability to identify root cause and implement sustainable corrective actions - Experience authoring or revising GMP documentation (SOPs, batch records, technical reports, deviation investigations, CAPAs, change controls, risk assessments) - Strong cross-functional collaboration skills and ability to work closely with Manufacturing, Quality, Engineering, and Supply Chain teams - Clear communication skills with ability to translate technical process observations into actionable recommendations NICE TO HAVE: - Master's degree or Ph.D. in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or related field - Experience in commercial-scale peptide manufacturing - Experience with process monitoring, Statistical Process Control, and process capability assessments - Lean Six Sigma Green Belt or Black Belt certification - Experience using statistical software and data analysis tools (Minitab, Power BI, Excel advanced analytics, or similar) - Experience in a startup or rapidly growing manufacturing organization

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