Senior Scientist – Manufacturing Science

Job Description

The Senior Scientist – Manufacturing Science provides technical support to achieve reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio, which includes raw materials, intermediates, enzymes, and bulk drug substances. The role executes technical projects—experimental, modeling, and production data analysis—to improve process control, yield, purity, and productivity. The scientist independently sets up and executes laboratory‑scale experiments, conducts research on manufactured products, and troubleshoots processes in the TS/MS laboratory.

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including interactions between chemistry and equipment.
• Execute technical projects to improve process control, yield, purity, and productivity.
• Provide technical support for preparing technical documents such as reports, change controls, regulatory submissions, deviation investigations, validation protocols, and summary reports.
• Develop and monitor metrics in real time to assess process variability and capability.
• Document and justify the state of validation (process and cleaning) using data that evaluate the manufacturing process’s capability to meet its purpose.
• Ensure accurate instruction sets (tickets & procedures) and process flow diagrams describe the process as performed and the control strategy.
• Support internal and joint process teams, and global/local PLOT teams.
• Independently set up and execute diverse chemical reactions.
• Design experiments with clear objectives, analyze data, and ensure proper documentation.
• Adhere to Good Laboratory Practice and CHP requirements.
• Write technical reports and documents.

• Bachelor’s degree in Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, or Analytical Chemistry.
• 3+ years of relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
• Authorized to work in the United States on a full‑time basis; no visa or work‑authorization support will be provided.

• 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 and as part of a team.
• Ability to prioritize activities and exercise good judgment and flexibility.

• Participation in a learning plan for API EM TS/MS Scientist.
• No certifications required.
• Tasks require access to manufacturing areas with appropriate PPE.
• Domestic and international travel (variable, up to 20%).

Actual compensation depends on education, experience, skills, and location. Anticipated wage range: $66,000 – $171,600. Full‑time employees are eligible for a company bonus, 401(k) plan, pension, vacation, medical, dental, vision, prescription drug, flexible spending accounts, life insurance, leave benefits, and well‑being benefits.

Lilly is an EEO Employer and does not discriminate on any legally protected status. Lilly is committed to providing accommodations for individuals with disabilities during the application process.