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 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 Associate Director – Head of TS/MS Lab will lead a technically comprehensive laboratory group to provide support to the Lebanon small molecule, peptide, and oligonucleotide manufacturing processes. Responsibilities include outfitting the TS/MS lab that is under construction, building a team, overseeing TS/MS business processes, directing experimentation in ongoing manufacturing support, business continuity and productivity project development. 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
- Understand the scientific principles of small molecule, peptide, and/or oligonucleotide manufacturing
- Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence
- Determine TS/MS staffing and resource needs and building the team to support laboratory operations through facility startup to enable successful process qualifications and validations
- Ensure representative laboratory scale-down models of process equipment and process analytical technologies are developed and implemented
- Review and approve GMP and GLP documentation including procedures, deviation investigations and technical reports
- Support 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
Basic Requirements:
- Bachelor's degree in biology, biochemistry, chemistry, chemical engineering, or related scientific discipline
- 5+ years of leadership experience and proven capabilities within small molecule, peptide, or oligonucleotide GMP manufacturing environment
Additional Skills/Preferences:
- Knowledge of qualification and validation requirements and good manufacturing and laboratory practices
- 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 work on own initiatives and as part process team consisting of a diverse group of management, production, laboratory, science and engineering professionals.
- Ability to respond quickly and proactively to changing priorities within a limited timeline