Biologics Manufacturing Specialist

Core Responsibilities

• Investigative Operations & Quality Release: Lead thorough investigations into operational deviations, process anomalies, and non-conformities across upstream and downstream suites. Facilitate cross-functional root cause analysis (RCA) sessions using tools like 5-Whys, Fishbone diagrams, and FMEA alongside Quality Assurance and subject matter experts. Evaluate product quality impact to support timely lot disposition.

• CAPA Management & Client Liaison: Draft, execute, and track Corrective and Preventive Actions (CAPAs), including post-implementation effectiveness verifications. Author comprehensive investigation reports detailing methodology, root causes, and risk evaluations. Present technical outcomes directly to external client representatives during scheduled operational reviews.

• Tech Transfer & Campaign Readiness: Support client technology transfers by creating and updating Master Batch Records (MBRs), SOPs, and operational documentation. Initiate change requests, complete operational risk evaluations, and conduct operator training prior to campaign launches.

• In-Campaign Support & Process Tracking: Track active CAPA milestones, process computerized system change controls (CSCCs), and coordinate non-conforming material disposition. Monitor daily floor metrics, address real-time operational issues, and track key departmental metrics.

Qualifications & Experience

• Education: Degree or Diploma in Biotechnology, Chemical Engineering, Bioengineering, Life Sciences, or a related technical discipline.

• Experience: 2 to 4+ years in a cGMP biopharmaceutical facility, with practical knowledge of upstream or downstream processing operations.
  

If you are interested in the position , kindly send your CVs in to jasper.soh(@)randstad.com.sg

Please include your availability, expected salary and reason for leaving your current job

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R25154228