PolyPeptide US
Production Scientist - Torrance
Torrance, CA, US · Full-time
Sponsorship not specified$90k-$125kDetected 6 days ago
Data AnalysisProject ManagementProcess ImprovementCustomer SupportGMPMass SpectrometryCommunicationCollaborationProblem SolvingPublic SpeakingWritingLean Manufacturing
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.
- 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.
- 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.
- Ability to manage multiple priorities in a fast-paced GMP manufacturing environment.
Requirements
- Proficiency with HPLC systems, cGMP processes, and data analysis.
- If you are motivated by technical problem-solving, GMP manufacturing, and cross-functional collaboration, we encourage you to apply.
Nice to have
- This position plays a key role in ensuring processes are well-documented, compliant, efficient, and ready for successful manufacturing.
- may vary depending on project needs, team structure, and individual role focus.
- Minimum of 5 years of experience in GMP pharmaceutical manufacturing or MS&T.
Compensation
- $90k-$125k
Benefits
- What We Are Looking For Education and Experience Advanced degree in Chemistry, Biochemistry, Engineering, or a related field.
Company info
- Prepare technical updates and presentations for internal teams, customers, and stakeholders.
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