Associate VP Technical Services​/Manufacturing Science; Indianapolis Parenteral Mfg

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.

This position provides leadership and strategic direction for the Parenteral Manufacturing Technical Services/Manufacturing Science (TS/MS) organization.

This includes management and governance of the technical agenda, support of the deviation and change control quality systems, ownership of operations batch records and applicable standard operating procedures, product/process monitoring, documenting, and maintaining product control strategies including risk assessments and documenting and maintaining the state of process/sterility assurance/cleaning validation.

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Provide strategic direction to TS/MS organization
• Provide leadership and governance to the technical/scientific agenda for the site via the Science Lead Team (process monitoring)
• Represent the TS/MS organization at the Site Lead Team
• Develop administrative and technical leadership with the organization
• Assure that appropriately trained and qualified staff are in place to provide day to day support and project support for new and existing products
• Process monitoring for continuous improvement of control strategy, risk reduction, maintenance of the validated state and for manufacturing productivity
• Establish reward and recognition initiatives for staff
• Communicate effectively with Parenteral TS/MS Network Director and other Parenteral TS/MS leaders to ensure alignment of technical agenda and Central TS/MS initiatives for molecule, sterility, and components.
• Serve as a key technical resource for regulatory interactions
• Manage commercialization agenda in partnership with PR & D and central TS/MS.

• 10+ years of prior leadership experience leading in parenteral manufacturing technical services
• Demonstrated regulatory inspection experience interacting with regulators directly

• Understanding of manufacturing and cGMPs
• Ability to prioritize efforts
• Effective written and oral communication skills
• Effective interpersonal skills
• Involvement in external pharmaceutical industry associations

• B.S. or equivalent in a scientific field of study

• Minimal travel required
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parental Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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