Production Scientist

Job Summary:

The 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:

• 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.)
• Perform Operational assessments.
• Prepare weekly slide deck presentations on project updates to internal and external stakeholders.
• 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)
• Author, prepare and support Deviations, process change controls, CAPA during project execution.
• Prepare Change Control Change Request and list of change document as part of MBPR generation (CC general and for MBPR)
• Draft and review Standard Operating Procedures (QUMAS)
• Conduct Risk Assessment (CRIA, RIA, FMEA)
• Approve quality documents as the production representative that does not need managers approval (MBPR, ARM, CR, SOP, PQE, validation documents, educational certificates etc.)
• Generate detailed Gannt chart of batch schedule.
• BOM generation and Process mapping (soon to include route & formula)
• 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.
• Project management of operation activities related to batch preparation/ execution (equipment/ IPC validation, hold time study, etc)
• Draft, format and improve MBPR template.
• Support technology transfer activities (generation of comparability report, identification of CPPs, review and approve validation PPQ documents, generation of BPR etc).
• Author and review campaign reports.
• Raw material OOS assessment
• Conduct Bottle neck analysis and Gap analysis of unit operations.
• Prepare Process capability analysis.
• Conduct cost analysis and forecasting.
• 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.
• Collaborate with PD to Design small scale experiments to support investigations or process improvement initiatives.
• Lead, mentor and train Operators and team members as part of upstream and downstream process knowledge transfer on MBPR and unit operations.
• Support continuous improvement initiatives.
• Manually Collect, trend, and analyze in process data as part of process monitoring to determine yields and change points.
• Support QA and regulatory with responding to comments by clients on executed BPR and NDA/BLA, submission.
• 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).
• Support regulatory review of documents.
• Process Mapping
• Routes and Formula on AX to be added to our responsibilities.

Qualifications:

Education & Experience

• Required Education:

• Advanced degree in chemistry, Biochemistry, Engineering, or a related field.

• Formal training or coursework in GMP, pharmaceutical manufacturing, or related regulatory standards is highly desirable.

• Relevant industry certifications (e.g., Lean Six Sigma, GMP compliance) are a plus.

• Experience:

• Minimum 5 years in pharmaceutical manufacturing GMP production or MS&T team, peptide manufacturing experience preferred.

• Proven ability to independently operate and troubleshoot production equipment and execute complex manufacturing procedures.

• Demonstrated success in working autonomously while managing multiple production tasks and priorities.

Skills & Competencies

• Technical Skills: Basic understanding about SPPS GMP manufacturing, Proficiency in HPLC systems, cGMP processes, Data analysis (Minitab experience is preferred).
• Soft Skills: Strong problem-solving, collaboration, Microsoft Data analysis (Minitab experience is preferred), Technical writing, and communication skills, and Microsoft office.
• Competencies:
• Strategic Scientific Judgment
• Quality and Regulatory Leadership
• Complex Problem Solving and Decision Making
• Technical Influence and Innovation
• Cross-Functional Leadership and Collaboration

Salary: $95K-$115K

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.