TS/MS Materials Sr. Principal Scientist/Advisor

Eli Lilly and Company; Lebanon (IN); On-site; USD 80,000 - 120,000; Full time

Job summary

Join a pioneering team at a state-of-the-art manufacturing facility in Lebanon, Indiana, where innovation meets compassion. This role offers the opportunity to lead raw material qualification and ensure the success of a greenfield project that will impact the production of life-changing medicines. As a key player, you will collaborate with diverse teams, tackle complex challenges, and drive solutions that enhance manufacturing operations. If you're passionate about making a difference in healthcare and thrive in a dynamic environment, this is the perfect opportunity for you to contribute to meaningful advancements in the industry.

Qualifications

• 5+ years of experience in the pharmaceutical industry.
• Bachelor's degree in a relevant scientific discipline.

Responsibilities

• Lead raw material selection and qualification for a new manufacturing site.
• Collaborate with cross-functional teams to ensure reliable supply of materials.
• Prepare and review technical documents to support manufacturing operations.

Skills

Raw material qualification

GMP manufacturing practices

Cross-functional collaboration

Problem-solving

Technical documentation

Communication skills

Education

Bachelor's degree in biology, biochemistry, chemistry, or related field

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 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

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.
• 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.
• Understand the scientific principles of small molecule, peptide, and/or oligonucleotide manufacturing.
• Provide 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 industry.

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.