Drug Product MSAT Scientist - Tech Transfer & GMP Execution

Germer International - Pharmaceutical Recruiting; King of Prussia (PA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Drug product formulation

Filling technologies

Technology transfer knowledge

Laboratory proficiency

Formation

BS in Chemical Engineering or Biology

MS in Chemical Engineering or Biology

Outils

Sterile filtration equipment

Single-use systems

Aseptic filling equipment

Description du poste

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.