Production Scientist - Peptide Manufacturing

About the role

PolyPeptide partners with pharmaceutical and biotech companies on peptide-based therapies, and is looking for a Production Scientist in Torrance, CA (full-time) to help scale process development work into GMP large-scale manufacturing. The scientist supports GMP manufacturing projects from technology transfer through production execution and post-campaign review, keeping processes documented, compliant, efficient and ready for manufacturing.

Key responsibilities

• Create and revise Master Batch Production Records based on Process Development Reports, ensuring appropriate scale-up and equipment compatibility.
• Review and support GMP documentation, including MBPRs, SOPs, change controls, FMEAs, risk assessments, PPQ documents, deviations, CAPAs and campaign reports.
• Provide on-floor and remote technical support during production, including troubleshooting and process monitoring.
• Support technology transfer from Process Development to Manufacturing.
• Collect, trend and analyze GMP and in-process data to monitor yields and support continuous improvement.
• Lead or support investigations using root cause analysis tools such as fishbone diagrams, interviews and 5 Whys.
• Support process and yield improvement initiatives, including bottleneck and gap analyses.
• Prepare technical updates and presentations for internal teams, customers and stakeholders.
• Collaborate with Production, QA, QC, Process Development, Project Management, Sales, Regulatory and Supply Chain.
• Train and support operators and team members on process knowledge, MBPR execution and unit operations.
• Maintain and update routes and formulas in AX.

Required profile

• Advanced degree in Chemistry, Biochemistry, Engineering or a related field.
• Minimum of 5 years of experience in GMP pharmaceutical manufacturing or MS&T; peptide manufacturing experience preferred.
• Formal training in GMP, pharmaceutical manufacturing or regulatory standards highly desirable.
• Experience operating and troubleshooting production equipment in a regulated environment.

Required skills

• Understanding of SPPS GMP manufacturing.
• Proficiency with HPLC systems, cGMP processes and data analysis.
• Minitab experience preferred.
• Strong technical writing, communication and problem-solving skills.
• Ability to work cross-functionally and manage multiple priorities in a fast-paced GMP environment.

Salary: $90K - $125K.