Sr. Scientist TSMS Dry External Manufacturing

Eli Lilly and Company-posted 2 months ago
$64,500 - $154,000/Yr
Full-time • Mid Level
Indianapolis, IN
5,001-10,000 employees
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

  • Provide the technical support and leadership required to achieve the reliable and compliant manufacture of the Dry Products External Manufacturing (Dry-EM).
  • Work with the technical staff responsible for the development and delivery of programs for continuous process optimization and improvement.
  • Understand the scientific principles required for manufacturing drug products, including the interaction of formulation and equipment.
  • Develop and steward operational control strategies.
  • Serve as a technical leader and mentor for Scientists, Managers, and other disciplines.
  • Maintain interface with the TS/MS function, development, customers, and contract manufacturing organizations.
  • Manage TS/MS technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, 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, processing records, procedures, PFDs, VMPs, etc.
  • Review/approve relevant technical documents, such as: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
  • Remain current with all the regulations (global GMP expectations, regulatory expectations, health, safety, and environmental regulations).
  • Provide support to internal and joint process teams.
  • Bachelor´s Degree or equivalent work experience in scientific disciplines of Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Biochemistry, Organic Chemistry, Physical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, Materials Science, or Engineering.
  • Minimum of 5 years of demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
  • Relevant industrial experience in dry operations technologies such as tablets and capsules manufacture focused on technical services and in any of the following disciplines such as Development, Manufacturing and or, Quality Assurance.
  • Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner.
  • A thorough understanding of cGMPs and drug product manufacturing.
  • Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment.
  • Good communication skills, especially attention to detail in written procedures and protocol development.
  • Capability to work in a virtual and complex environment.
  • Willingness to travel.
  • Appreciation for cultural diversity and inclusive leadership.
  • Experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools & principles.
  • Ability to work independently as well as part of a team.
  • Ability to prioritize activities.
  • Good judgment and flexibility.
  • Eligibility to participate in a company-sponsored 401(k); pension.
  • Vacation benefits.
  • Eligibility for medical, dental, vision and prescription drug benefits.
  • 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).
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