Senior MS&T Scientist: Sterile Process Transfer

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, Inc. is seeking a Senior Scientist – MS&T to drive development, scale-up, technology transfer, validation, and commercial manufacturing of sterile products.

You will bridge R&D, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to ensure robust, compliant product commercialization. The role requires PhD/advanced degree, 7+ years in MS&T, and hands-on experience with sterile processes, process validation, and lifecycle management.

Qualifications

• 7+ years in MS&T or related pharmaceutical roles.
• Experience with sterile, injectable, or parenteral manufacturing.
• Proven ability to lead tech transfer and validation activities.
• Familiarity with cGMP, FDA/ICH/global regulations.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Provide technical leadership for manufacturing processes.
• Lead technology transfer from R&D to manufacturing.
• Design and support process validation, CPV and PPQ activities.
• Mentor scientists and collaborate with QA, Regulatory, and Operations.

Skills

MS&T experience

Process development

Technology transfer

Root cause analysis

CAPA investigations

Regulatory compliance

Education

PhD in Pharmaceutical Sciences

Master's degree considered

Job description

Nivagen Pharmaceuticals, Inc. is seeking a Senior Scientist – MS&T to drive development, scale-up, technology transfer, validation, and commercial manufacturing of sterile products.

You will bridge R&D, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to ensure robust, compliant product commercialization. The role requires PhD/advanced degree, 7+ years in MS&T, and hands-on experience with sterile processes, process validation, and lifecycle management.