About the Position
As a Senior Scientist in Manufacturing Science, you will provide technical support for the reliable and compliant manufacture of API External Manufacturing portfolio. The ideal candidate will execute technical projects to enhance process control, yield, purity, and/or productivity.
Key Responsibilities
* Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of chemistry and equipment.
* Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
* Provide technical support for preparation of relevant technical documents, such as technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports.
* Develop and monitor established metrics in real-time to assess process variability and capability.
* Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
* Ability to independently set up and execute various chemical reactions.
* Ensure that experiments are well designed with clear objectives.
* Ability to analyze data and ensure appropriate documentation.
Requirements
* 3+ years of relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
* 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.
Education Requirements
* PhD or equivalent in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.