Associate Director - Technical Operations and Commercialization

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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 Associate Director - Technical Operations and Commercialization will build and lead a diverse team of scientists and project managers at the Lebanon small molecule, peptide, and oligonucleotide drug substance manufacturing site. Responsibilities include guiding validation strategy, API commercialization, material selection, and cleaning strategy for the site. In this role you will work collaboratively with peers in the quality control laboratory, engineering, development and quality assurance.

• Guide the commercialization of efforts of new APIs into the Lebanon plant
• Lead a team that provides technical guidance on raw material selection
• Define cleaning strategy for the compounds made in the plant
• Assess ongoing manufacturing processes and make recommendations for improvements
• Understand the scientific principles of small molecule, peptide, and/or oligonucleotide manufacturing
• Support site leadership to build a diverse and capable TS/MS (Technical Services/Manufacturing Science) 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 validations
• Review and approve GMP and GLP documentation including procedures, deviation investigations and technical reports
• 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 experience and proven capabilities within small molecule, peptide, or oligonucleotide GMP manufacturing environment

Additional Skills/Preferences:

• Advanced science degrees are a plus.
• Knowledge of qualification and validation requirements and good manufacturing and laboratory practices
• Knowledge of clinical and commercial GMP manufacturing processes
• Understanding API cleaning strategies
• Experience with raw material selection
• Strong written and verbal communication skills
• Experience with continuous processing is a plus
• Experience with process validation 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

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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