Senior Scientist – Manufacturing Science

About the role

The Senior Scientist – Manufacturing Science provides technical support to achieve reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio, including raw materials, intermediates, enzymes, and bulk drug substances. This role executes technical projects (experimental, modeling, and/or production data analysis) to improve process control, yield, purity, and/or productivity. The Senior Scientist will independently set up and execute laboratory-scale experiments, conduct research for process improvements, and troubleshoot manufactured products in the TS/MS laboratory.

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 preparing relevant technical documents, 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 evaluating the capability of the manufacturing process to meet its stated purpose.
• Ensure accurate instruction sets (tickets & procedures) and PFDs describe the process as performed and the control strategy for discrete manufacturing steps.
• Provide support to internal and joint process teams and to global and local PLOT teams.
• Independently set up and execute various chemical reactions.
• Design experiments with clear objectives, analyze data, and ensure appropriate documentation.
• Adhere to safe laboratory practices and CHP requirements.
• Write technical reports and documents.

Requirements

• 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.
• Authorization to work in the United States on a full-time basis (Lilly will not sponsor work authorization or visas for this role).

Preferred Qualifications

• 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 and as part of a team.
• Strong prioritization and judgment skills with flexibility.

Other Information

• Complete learning plan for API EM TS/MS Scientist.
• Tasks may require entering manufacturing areas, which necessitates wearing appropriate PPE.
• Domestic and international travel (variable, up to 20%).

Pay

The anticipated wage for this position is $66,000 - $171,600, depending on education, experience, skills, and geographic location. Full-time employees are also eligible for a company bonus based on performance.

Benefits

• Comprehensive benefit program, including medical, dental, vision, and prescription drug benefits.
• Company-sponsored 401(k) and pension plans.
• Vacation benefits and flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).