Senior Scientist – Manufacturing Science

Key Objectives/Deliverables

The Senior Scientist – Manufacturing Science provides the technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The Senior Scientist – Manufacturing Science executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity.

Provides technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.

Develops and monitors established metrics in real-time to assess process variability and capability.

Understands, justifies and documents the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.

Ensures that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.

Supports internal and joint process teams and to the global and local PLOT teams.

Ability to independently set up and execute various chemical reactions.

Analyzes data and ensures appropriate documentation.

Utilizes safe laboratory practice and adheres to CHP requirements.

Writes technical reports and documents.

Basic Requirements

• Bachelor's degree in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.
• 3+ years of relevant industrial experience in any of the following disciplines such as API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.

Additional Preferences

• Demonstrated basic knowledge in small molecule API Manufacturing.
• Familiarity with cGMP manufacturing environment and terminology.
• Excellent analytical, interpersonal, written and oral communication skills.
• Ability to work independently as well as part of a team.
• Ability to prioritize activities.
• Good judgment and flexibility.