Associate Production Scientist

Job Summary:

"The Associate Production Scientist is responsible for a upscaling R&D small scale work into GMP large scale manufacturing, Oversee production activities of the assigned projects, collect and analyze GMP data, Author and review quality documents such as MBPR, R.A, PPQ protocol, drive yield and process improvement projects, update the customer with the GMP activities, ensuring production processes meet quality standards, or maintaining equipment efficiency]. This role contributes directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers."

Key Responsibilities:

List the key tasks and duties for the role. Use action verbs and make each responsibility specific and measurable. Prioritize by importance.

1. Review and approve quality and validation documents as the production representative that does not need managers approval (MBPR, CC, SOP, PQE, PPQ related documents, educational certificates etc.)
2. Perform Operational assessments.
3. Prepare weekly slide deck presentations on project updates to internal and external stakeholders.
4. Lead and/or prepare and/or support product investigations using root cause analysis techniques (interviewing, fishbone diagram, 5 whys etc) and summarizing findings in written reports and oral presentations to internal and external stakeholders (QIRM, OOT, OOS, RCI, CAPA/Task)
5. Author, prepare and support Deviations, process change controls, CAPA during project execution.
6. Prepare Change Control Change Request and list of change document as part of MBPR generation (CC general and for MBPR)
7. Draft and review Standard Operating Procedures (QUMAS)
8. Conduct Risk Assessment (CRIA, RIA, FMEA)
9. Approve quality documents as the production representative that does not need managers approval (MBPR, ARM, CR, SOP, PQE, validation documents, educational certificates etc.)
10. Generate detailed Gannt chart of batch schedule.
11. BOM generation and Process mapping (soon to include route & formula)
12. Provide on-floor and remote 24/7 technical support to Production during project execution (including weekends, grave, and night shifts), e.g. make go/no go decisions on IPC-results regarding process steps or troubleshooting issues.
13. Project management of operation activities related to batch preparation/ execution (equipment/ IPC validation, hold time study, etc…)
14. Draft, format and improve MBPR template.
15. Support technology transfer activities (generation of comparability report, identification of CPPs, review and approve validation PPQ documents, generation of BPR etc).
16. Author and review campaign reports.
17. Raw material OOS assessment
18. Conduct Bottle neck analysis and Gap analysis of unit operations.
19. Prepare Process capability analysis.
20. Conduct cost analysis and forecasting.
21. Liaise with cross functional groups (Production, QA, QC, Development, Project Management, Sale, Regulatory, Supply Chain etc.) to support the planning and execution of manufacturing operations.
22. Collaborate with PD to Design small scale experiments to support investigations or process improvement initiatives.
23. Lead, mentor and train Operators and team members as part of upstream and downstream process knowledge transfer on MBPR and unit operations.
24. Support continuous improvement initiatives.
25. Manually Collect, trend, and analyze in process data as part of process monitoring to determine yields and change points.
26. Support QA and regulatory with responding to comments by clients on executed BPR and NDA/BLA, submission.
27. Support Validation activities during the planning execution of PPQ runs (prepare supporting PPQ document, e.g. equipment calibration and suitability, analytical methods, hold time study, PPQ strategy etc).
28. Support regulatory review of documents.
29. Process Mapping
30. Routes and Formula on AX to be added to our responsibilities 

Qualifications:

Education & Experience

• Required Education: Bachelor’s degree in chemistry, Biochemistry, Engineering, or a related field.
• Preferred Education: Masters degree preferred, advanced degree or certifications bachelor’s degree in chemistry, Biochemistry, Engineering.
• Experience: Minimum 3 years in pharmaceutical manufacturing GMP production or MS&T team, peptide manufacturing experience preferred.

Skills & Competencies