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Principal Scientist - Drug Product Formulation - TSMS

Eli Lilly and Company
Durham, North Carolina
Start date
Nov 29, 2023

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Marketing, Science/R&D, Biotechnology, Pharmacology
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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.

Eli Lilly and Company seeks a Principal Scientist – Drug Product Formulation - TSMS to apply the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems to provide technical support for technical transfers and process validation, including support of equipment qualification and validation. Perform the following duties: author standard operating procedures, as they relate to the activities of the TS/MS group; provide technical support, including quality and stability consultations for non-routine investigation such as deviations and complaints; prepare, review, approve, and provide technical support for preparation of relevant technical documents, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, and QPPAs; ensure that an accurate instruction set describes the process as performed and the control strategy for the discrete manufacturing steps; support and own the technical agenda for the product or validation process; lead risk management activities as it pertains to products and processes; develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability; apply manufacturing process knowledge and data analysis skills to support the management of daily manufacturing operations; support the TS/MS technical projects to ensure a successful start-up, improvement process control, yield, product quality and productivity; implement process changes and improvements through the technical agenda; serve as technical interface external to the RTP site; provide audit support, as needed; work within or lead cross functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives; collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain; ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Position requires a Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry or related quantitative field, and 5 years of experience in cGMP manufacturing, specifically within Operations, Validation, Engineering, Technical Services/MSAT, or Quality Assurance. Must have experience with: Parenteral drug product manufacturing; TS/MS, MSAT, or Operations, particularly with formulation of parenteral drug products; Technical Transfer, including equipment qualification and process validation; Statistical data trending and analysis (using statistical packages such as JMP); Performing the technical assessments and evaluations required to support deviation and change management, as well as experience with the respective execution systems, including Trackwise; and Performing process risk assessment (e.g. FMEA). 

Job location: Durham, NC. To apply, please visit and enter job requisition number R-53422 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Beth L. Berry, Lilly Corporate Center, Indianapolis, IN 46285.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.



Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
893 S Delaware St
United States

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