Manufacturing Science & Technology (MSAT) Team Member
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Job Description
We are looking for MSAT team member who will serve as the technical bridge between process development and commercial production. Operating within a cGMP environment, this role provides end-to-end technical oversight, process engineering expertise, and scientific support to ensure the robust, scalable, and safe manufacture of Active Pharmaceutical Ingredients (APIs). The successful candidate will drive technology transfers, lead complex root-cause investigations, and champion continuous process improvement (CPI) to optimize product yield and quality.
Responsibilities:
1. Technology Transfer & Scale-Up
• Support the technical transfer of new API / Intermediate chemical synthesis processes from MSAT lab or external customers into commercial-scale manufacturing.
• Conduct laboratory experiments for feasibility studies and / or continuous improvement purpose.
• Perform facility-fit assessments, chemical engineering calculations (e.g., mass/energy balances, heat transfer, mixing dynamics), and scale-up modeling.
• Draft, review, and execute Technology Transfer Protocols, Campaign Summary Reports, and regular technical risk assessments (FMEA).
• Support to the EHS department in analysis the process safety data and interpretation.
2. Process Validation & Monitoring
• Support to the Validation program Process / clean protocols and Continued Process Verification (CPV) plans in alignment with ICH guidelines and Quality compliance requirements.
• Provide real-time shop floor technical support during active manufacturing campaigns and validation batches.
3. Deviation, Investigation & CAPA Management
• Act as the Technical Subject Matter Expert (SME) for manufacturing deviations, batch failures, and out-of-specification (OOS) results.
• Utilize structured root-cause analysis (RCA) tools (e.g., Fishbone, 5 Whys) to determine technical root causes and implement robust Corrective and Preventive Actions (CAPAs).
4. Continuous Improvement & Lifecycle Management
• Identify and implement process optimization initiatives to enhance yield, minimize impurity profiles, reduce solvent consumption, and cut cycle times.
• Manage technical aspects of lifecycle changes, authoring technical justifications for change controls.
5. Regulatory & Compliance Support
• Support the technical queries for regulatory filing queries.
• Participate as a technical SME during regulatory inspections and client audits.
Requirements
Function: Manufacturing
Experience Level: Entry Level