Sr Principal/Advisor - TS/MS API Lab

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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.

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 leadership 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 TS/MS Lab will be the point person for developing experimentation to provide support to the Lebanon small molecule, peptide, and oligonucleotide manufacturing processes. This person will also provide key guidance on equipment and instrumentation to support the required laboratory experimentation. In this role you will work collaboratively with peers in the quality control laboratory, engineering, development and quality assurance.

• Assisting in the design and outfitting of the TS/MS lab that is being built with to deliver a lab that can fulfill the requirement of supporting Lilly's manufacturing portfolio
• Understanding the scientific principles of small molecule, peptide, and/or oligonucleotide manufacturing
• Ensuring representative laboratory scale-down models of process equipment and process analytical technologies are developed and implemented
• Reviewing and approving GMP and GLP documentation including procedures, deviation investigations and technical reports
• Supporting the project team to ensure the TS/MS laboratory is delivered to the site lead team ready to operate safely to support facility startup
• Facilitating process transfer from other sites and process characterization and first-time validation
• 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
• Participating in development and implementation of process improvement, including capital expansions and technical projects.
• Working within cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Interacting with process teams to identify improvement and productivity objectives and drive the technical agenda within area of responsibility.
• Interfacing with the greater scientific community to benchmark practices, network with external partners, and provide technical oversight

Basic Requirements:

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

Additional Skills/Preferences:

• Knowledge of qualification and validation 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
• Experience with continuous processing is a plus
• Experience with process characterization is a plus
• 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 ( ) 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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