Senior Scientist – Manufacturing Science

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

The Senior Scientist – Manufacturing Science provides technical support for the reliable and compliant manufacture of API External Manufacturing (API EM) portfolio, including raw materials, intermediates, enzymes, and bulk drug substances. This role executes technical projects involving experimentation, modeling, and data analysis to optimize process control, yield, purity, and productivity. Responsibilities include conducting laboratory-scale experiments, troubleshooting, and providing technical documentation for regulatory submissions and process improvements within a cGMP manufacturing environment.

What you'd actually do

  1. Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
  2. 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.
  3. Develop and monitor established metrics in real-time to assess process variability and capability.
  4. 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.
  5. Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.

Skills

Required

  • Bachelors degree in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.
  • 3+ years of relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
  • 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

Nice to have

  • 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.

What the JD emphasized

  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.