Production Scientist - Torrance
About The Position
Support the scale-up of peptide manufacturing from development to GMP production. At PolyPeptide, we partner with pharmaceutical and biotech companies to support the development and manufacturing of peptide-based therapies. We are looking for a Production Scientist to help scale Process Development work into GMP large-scale manufacturing. This role is ideal for someone who enjoys technical problem-solving, GMP documentation, manufacturing support, data analysis, and cross-functional collaboration. 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.
Requirements
- Advanced degree in Chemistry, Biochemistry, Engineering, or a related field.
- Minimum of 5 years of experience in GMP pharmaceutical manufacturing or MS&T.
- Experience operating and troubleshooting production equipment in a regulated environment.
- Understanding of SPPS GMP manufacturing.
- Proficiency with HPLC systems, cGMP processes, and data analysis.
- 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.
Nice To Haves
- 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.
- Minitab experience is preferred.
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 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.
Benefits
- We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
