Production Scientist
PolyPeptide Group, Torrance, CA, Onsite
Manufacturing ProductionMaster RequiredSenior
About the role
About the Role
The Production Scientist supports assigned GMP manufacturing projects from technology transfer through production execution and post-campaign review. This position plays a key role in ensuring processes are well-documented, compliant, efficient, and ready for successful manufacturing.
Responsibilities may vary depending on project needs, team structure, and individual role focus.
What You Will Do
- 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 execution, including troubleshooting and process monitoring.
- Support technology transfer activities from Process Development to Manufacturing.
- Collect, trend, and analyze GMP and in-process data to monitor yields, identify process changes, 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 to support accurate documentation and material forecasting.
What We Are Looking For
Education and Experience
- 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 is preferred.
- Formal training in GMP, pharmaceutical manufacturing, or regulatory standards is highly desirable.
- Lean Six Sigma, GMP compliance, or related certifications are a plus.
- Experience operating and troubleshooting production equipment in a regulated environment.
Skills and Competencies
- Understanding of SPPS GMP manufacturing.
- Proficiency with HPLC systems, cGMP processes, and data analysis.
- Minitab experience is preferred.
- Strong technical writing, communication, and problem-solving skills.
- Ability to work cross-functionally with technical, quality, operational, and commercial teams.
- Strong attention to detail and commitment to quality, compliance, and data integrity.
- Ability to manage multiple priorities in a fast-paced GMP manufacturing environment.
Why Join PolyPeptide?
In this role, you will help bring complex peptide processes from development into GMP manufacturing. Your work will support critical production campaigns, customer programs, process improvements, and the manufacturing of peptide-based therapies.
If you are motivated by technical problem-solving, GMP manufacturing, and cross-functional collaboration, we encourage you to apply.
About PolyPeptide US
PolyPeptide is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide and oligonucleotide-based active pharmaceutical ingredients (API). By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world.
PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1.
Dating back to 1952, PolyPeptide today runs a global manufacturing network in Europe, the U.S. and India.
Founded in 1996