Drug Product MSAT Engineer - #1133122

Drug Product MSAT (Manufacturing Science & Technology)

Location: 2 Tuas View Drive, Singapore 639059

Job Summary

The Drug Product MSAT role serves as the technical owner of the drug product manufacturing process. The position bridges R&D, Manufacturing, Quality, and Engineering to ensure that drug product processes are scientifically sound, robust, compliant, and capable of consistent commercial execution.

Drug Product MSAT is accountable for translating development knowledge into reliable manufacturing processes, providing technical decision-making during routine production, and continuously improving process performance throughout the product lifecycle.

Responsibilities

1.       Drug Product Project FL (Functional Lead) for Process Lifecycle Management, Technology Transfer and Scale-Up

· Serve as technical point of contact on MSAT-related topics. Participate in:  

• Internal and external projects meetings

• Technical discussions

· Translate client requirements into practical and compliant manufacturing solutions.

· Collaborate closely with CMC, Project Management, R&D, QA, QC, Supply Chain, Engineering.

• Lead or support technology transfer of sterile and lyophilized drug products from:

  • Internal site -> site (global network)

  • Client -> Manufacturing site

• Author process transfer documents (Process Flow Diagram, Manufacturing Batch Records, etc.).

• Assess risks related to equipment, facility, and process differences, and define mitigation strategies.

• Provide on-floor MSAT support during engineering, clinical GMP, PPQ, and commercial batches.

• Support product lifecycle activities including:

  • Design and execute PPQ strategies in accordance with regulatory expectations.

  • Establish and maintain CPV programs, including data trending and statistical evaluation.

  • Interpret process data to identify early signals of variability or loss of control.

2.       Deviation and Change Management

• Lead or contribute to root cause investigations for deviations.

• Apply structured problem-solving tools such as Fishbone diagrams, 5M, 5 Whys.

• Define and implement science-based CAPAs addressing true technical root causes.

• Perform change impact assessments (facility, process, equipment, material, regulatory filing).

3.       Manufacturing Technical Support

• Lead or support facility readiness risk assessments prior to GMP release.

• Serve as a technical subject matter expert (SME) during internal, client and regulatory inspections.

• Provide advanced technical support, including but not limited to:

  • Design, execute, and interpret lyophilization-related technical studies

  • Drive process and facility operation optimization initiatives (e.g. Kaizen, continuous improvement)

  • Apply process capability analysis (e.g. Cpk) to evaluate critical process and equipment performance.

Required Qualifications

• Solid understanding of GMP requirements (EU GMP, FDA) and tech transfer activities is highly preferred.

• Experience in a CDMO or multi-product environment is a strong advantage.

• Ability to work with multiple clients and products in parallel

• Clear technical communication (written & verbal)

• Structured problem-solving and risk-based thinking

• Comfortable working in a fast-paced, regulated environment

For Associate Engineer

· Bachelor or higher in Pharmaceutical Manufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, or related fields.

· Personnel with 1 or 2 years of relevant experiences in pharmaceutical industry.

Senior level depends on experience in sterile drug product manufacturing or MSAT