Scientist, Drug Product

Germer International - Pharmaceutical Recruiting; King of Prussia (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting seeks a Scientist, Drug Product MSAT to lead technology transfer for viral vector pilot ENG and GMP manufacturing campaigns. This role requires collaboration with process development and manufacturing to ensure successful GMP execution.

The ideal candidate will have hands-on experience with drug product formulation, sterile filtration, aseptic filling, and related documentation to enable efficient knowledge transfer and mentorship for junior staff.

Qualifications

• BS or MS with experience in drug product formulation and filling technologies and laboratory proficiency.
• Hands-on experience with common drug product formulation and fill equipment and ability to train junior staff.

Responsibilities

• Work with process development or client to transfer knowledge for scale-up to pilot and GMP operations.
• Sterile Filtration and Product Transfer experience.
• Aseptic Filling, vial capping and visual inspection experience.
• Provide planning and logistics support for GMP execution.
• Author knowledge transfer documentation for GMP manufacture (BOMs, PFDs, sample plans).
• Collaborate with process development and manufacturing to establish technology transfer plan and perform risk assessment for GMP introduction.

Skills

Drug product formulation

Filling technologies

Technology transfer knowledge

Laboratory proficiency

Education

BS in Chemical Engineering or Biology

MS in Chemical Engineering or Biology

Tools

Sterile filtration equipment

Single-use systems

Aseptic filling equipment

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.
• Sterile Filtration and Product Transfer axperience
• Aseptic Filling, vial capping and visual inspection experience
• 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.