Senior Scientist - Manufacturing Science

Senior Scientist - Manufacturing Science

Eli Lilly Benelux

Kinsale, Ireland

Job Description:

The API EM TS/MS Scientist 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 API EM TS/MS Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the TS/MS scientist should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the TS/MS laboratory.

Key Objectives/Deliverables:

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the 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, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.;
• Develop and monitor established metrics in real-time to assess process variability and capability;
• Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose;
• Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps;
• Provide support internal and joint process teams and to the global and local PLOT teams;
• 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;
• Utilize save laboratory practice and adhere to CHP requirements;
• Write technical reports and documents.

Basic Requirements:

• 3+ years of relevant industrial experience in any of the following discipline 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.

Education Requirements:

• PhD or equivalent in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.

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