Manufacturing Scientist - Lebanon API Manufacturing
Location: Lebanon, Indiana, United States of America
Category: Manufacturing/Quality
Job Type: Full Time, Regular
Job Id: R-62025
Company Overview:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. Our mission is to unite caring with discovery to improve lives worldwide. Our 35,000 employees strive to discover and deliver life-changing medicines, enhance disease management, and contribute to our communities through philanthropy and volunteerism.
Lilly is constructing an advanced API manufacturing facility in Lebanon, IN, representing the company’s largest investment in manufacturing capacity. This site will supply APIs for current and future products, including new modalities. The successful candidate will play a key role in building processes and systems to enable a successful startup of GMP manufacturing operations.
Organization Overview:
The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team, providing technical support for reliable and compliant API manufacturing. The role involves daily oversight to ensure safe and consistent supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling, and/or production data analysis) to optimize process control, yield, purity, and productivity. This role also requires setting up and executing laboratory-scale experiments and conducting research to troubleshoot and enhance manufacturing processes.
Responsibilities:
Understand the scientific principles involved in manufacturing intermediates and bulk drug substances, considering chemistry and equipment interactions.
Execute technical projects to improve process control, yield, purity, and productivity.
Provide technical support for preparation of relevant documents such as technical reports, change controls, regulatory submissions, deviation investigations, validation protocols, and process records.
Develop and monitor real-time metrics to assess process variability and capability.
Justify and document the state of validation (process and cleaning) with supporting data.
Ensure that process instructions (tickets and procedures) and PFDs accurately describe the process and control strategy.
Design and execute experiments with clear objectives.
Analyze data and ensure appropriate documentation.
Write technical reports and related documents.
Basic Requirements:
Bachelor's degree in STEM discipline (Chemistry preferred) with at least 3 years of experience in cGMP manufacturing, or Master’s degree with 1 year of experience in cGMP manufacturing.
Additional Preferences:
Basic knowledge of small molecule, peptide, or oligonucleotide API manufacturing.
Relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
Familiarity with cGMP manufacturing environment and terminology.
Strong analytical, interpersonal, written, and oral communication skills.
Ability to work independently and as part of a cross-functional team.
Creativity to identify improvement opportunities and initiative to implement them.
Ability to mentor and guide others.
Flexibility to meet business needs.
EEO Statement:
Lilly is an EEO/Affirmative Action Employer that does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Accommodations:
Lilly is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance during the application process, please complete the accommodation request form at Workplace Accommodation.
Employee Resource Groups (ERGs):
Our ERGs provide strong support networks for their members and contribute to the development of future leaders. Current groups include:
African American Network
PRIDE (LGBTQ + Allies)
Women’s Network
Veterans Leadership Network
And many more
#WeAreLilly
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