Eli Lilly and Company
Scientist - TSMS Dry External Manufacturing
Eli Lilly and Company, Carolina, Carolina, us, 00985
Scientist - TSMS Dry External Manufacturing
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Scientist - TSMS Dry External Manufacturing
role at
Eli Lilly and Company
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.
Responsibilities The TSMS Representative role provides the technical support and leadership required to achieve the reliable and compliant manufacture of the Dry Products External Manufacturing (Dry‑EM). The TSMS Representative works 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 (technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.).
Review/approve relevant technical documents (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.
Basic Qualifications
Education: 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.
Experience: 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 in Development, Manufacturing and/or Quality Assurance.
Skills: Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner; thorough understanding of cGMPs and drug product manufacturing; strong leadership, interpersonal and teamwork skills; 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; experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools & principles.
Additional Skills / Preferences
Experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
Ability to work independently as well as part of a team.
Ability to prioritize activities.
Good judgment and flexibility.
Additional Information
Off‑hours may be necessary to support operations.
Travel possible, up to 30%.
Equal Opportunity Employer Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides accommodations. Lilly is an equal‑opportunity employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 – $171,600. Full‑time employees will also be eligible for company bonuses and a comprehensive benefits program.
Referrals increase your chances of interviewing at Eli Lilly and Company by 2x.
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Scientist - TSMS Dry External Manufacturing
role at
Eli Lilly and Company
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.
Responsibilities The TSMS Representative role provides the technical support and leadership required to achieve the reliable and compliant manufacture of the Dry Products External Manufacturing (Dry‑EM). The TSMS Representative works 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 (technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.).
Review/approve relevant technical documents (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.
Basic Qualifications
Education: 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.
Experience: 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 in Development, Manufacturing and/or Quality Assurance.
Skills: Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner; thorough understanding of cGMPs and drug product manufacturing; strong leadership, interpersonal and teamwork skills; 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; experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools & principles.
Additional Skills / Preferences
Experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
Ability to work independently as well as part of a team.
Ability to prioritize activities.
Good judgment and flexibility.
Additional Information
Off‑hours may be necessary to support operations.
Travel possible, up to 30%.
Equal Opportunity Employer Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides accommodations. Lilly is an equal‑opportunity employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 – $171,600. Full‑time employees will also be eligible for company bonuses and a comprehensive benefits program.
Referrals increase your chances of interviewing at Eli Lilly and Company by 2x.
#J-18808-Ljbffr