TS/MS Materials Sr. Principal Scientist/Advisor

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.

Job Description

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 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Responsibilities

The Sr. Principal Scientist/Advisor Materials will be the technical lead for raw material selection and qualification and raw material deviation investigations for the Lebanon small molecule, peptide, and oligonucleotide manufacturing plant. In this role you will work collaboratively with peers in the quality control laboratory, engineering, development and quality assurance.

• Define raw material qualification strategy for the Lebanon site
• Work effectively and efficiently in a cross-functional team with Quality Control, Quality Assurance, Operations Planning, and Procurement to ensure reliable supply of raw materials and consumables.
• Lead technical evaluations of second sources of key raw materials and consumables to firm up supply chain.
• Own extractable and leachables risk assessments as needed to support commercial manufacturing.
• Anticipate and resolve complex problems. Drive solutions that impact the site.
• Prepare, review, approve, and provide technical support for the preparation of relevant technical documents such as change controls, operating procedures, deviation investigations, plant trial protocols and summary reports, procedures, and technical reports.
• Provide technical support during the evaluation of supplier change notifications.
• Own materials components of Annual Product Reviews, Management System Reviews, etc.
• Assist in regulatory filings, as necessary
• Work with manufacturing Process Team counterparts to assess/investigate material issues and implement materials changes.
• Design experimental and testing plans as needed to perform effective, data-driven assessments
• Understanding the scientific principles of small molecule, peptide, and/or oligonucleotide manufacturing
• Providing technical support to non-routine (e.g., deviation) investigations including evaluating materials from production in laboratory analysis to ensure no impact to product quality

Basic Requirements:

• Bachelor's degree in biology, biochemistry, chemistry, chemical engineering, or related scientific discipline
• 5+ years of experience in the pharmaceutical indust

Additional Skills/Preferences:

• Knowledge of raw material qualification requirements and good manufacturing and laboratory practices
• Experience mentoring junior staff
• Knowledge of clinical and commercial GMP manufacturing processes
• Strong written and verbal communication skills
• Ability to respond quickly and proactively to changing priorities within a limited timeline

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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