MSAT Scientist, Drug Product

Germer International - Pharmaceutical Recruiting; Malvern (Chester County); On-site; USD 85,000 - 125,000; Full time

Job summary

Germer International is sourcing a Scientist, Drug Product MSAT for a biopharmaceutical client. The role centers on leading drug product tech transfer for viral vector processes and GMP campaigns.

Responsibilities include coordinating with process development, supporting GMP-scale operations, and producing transfer documentation such as BOMs and PFDs. Requires a strong background in drug product formulation and fill technologies.

Qualifications

• BS in Chemical Engineering, Biology, or life sciences with related drug product formulation experience.
• MS degree with 2+ years in drug product formulation or MSAT is ideal.
• Hands-on experience with filling equipment and sterile processes.

Responsibilities

• Lead drug product MSAT tech transfer activities for viral vector pilot, ENG, and GMP campaigns.
• Collaborate with process development and manufacturing to scale up for pilot and GMP operations.
• Author knowledge transfer documentation for GMP manufacture (BOMs, PFDs, sample plans).
• Support evaluation and risk assessment for technology transfer to GMP facilities.

Skills

MSAT knowledge

Tech transfer

Process knowledge

Education

BS in Chemical Engineering

MS in Chemical Engineering or Life Sciences

Tools

Filling equipment

Sterile filtration

Aseptic process simulation

Single-use systems

Job description

Our client, a biopharmaceutical organization is hiring a Scientist, Drug Product MSAT. The ideal candidate has experience supporting drug product MSAT technology transfer activities for viral vector pilot, ENG, and GMP manufacturing campaigns. The Scientist, Drug Product MSAT will play a critical role in leading drug product tech transfer for associated clinical and commercial vector processes.

Primary Responsibilities:

• Work closely with process development and/or client in process knowledge transfer to scale-up process for pilot and GMP operations.
• Support Process Fit to Plant evaluation.
• Provide planning and logistics support for GMP execution.
• Author knowledge transfer documentation for GMP manufacture (e.g., bill of materials, process flow diagrams, and sample plans).
• Collaborate with process development scientists and manufacturing to establish technology transfer plan and perform technical risk assessment for the product/process introduction to the GMP facility.

Education, Experience and Qualifications:

• BS (4+ years’ experience) or MS (2+ years’ experience) in Chemical Engineering, Biology, or similar life sciences degree with experience in drug product formulation and filling technologies and demonstrated laboratory proficiency.
• Hands‑on experience with common drug product formulation and fill equipment, materials and operations (i.e., automated and semi-automated filling equipment, sterile filtration, filter integrity testing, aseptic process simulation, single use systems, etc.) and ability to train junior staff.