Associate Director - Technical Services

Associate Director for Technical Services

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.

Main Purpose and Objective of Position: The Bioprocess Operations team within Bioproduct Research and Development (BRD) is responsible for the manufacture of drug substance (DS) to support clinical trials within the BRD portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates and adeno associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. The Associate Director for Technical Services manages functional responsibilities for the technical services, environmental monitoring and process microbiology groups within the Clinical Trial Bioprocess Pilot Plant, which is focused on producing bulk drug substance (API) for clinical trials.

Key Responsibilities:

• Responsible for recruiting, onboarding, career development, coaching, performance management, and succession planning for scientists and engineers.
• Instills technical rigor, ensures thorough root cause investigations pertaining to all applicable deviations, and drives for continuous improvement in operational excellence.
• Enables and maintains a robust process monitoring program.
• Serves as a liaison between development, manufacturing and the pilot plant for activities related to process transfer.
• Determines resourcing for new projects and makes assignments within the organization.
• Ensures compliance of staff with all applicable HSE and Quality System and data integrity requirements.
• Ensure staff training requirements are clearly articulated and staff are properly trained to perform assigned duties.
• Ensure clear assignment of system ownership for relevant technical services and microbiology computer systems and instruments.
• Ensures GMP compliance of facilities, processes, and documentation in the Clinical Trial Bioprocess Pilot Plant and the organization remains in a state of inspection readiness.
• Ensures GMP compliance with environmental monitoring and campaign change-over processes within the Clinical Trial Bioprocess Pilot Plant.
• Reviews and approves relevant deviations, change controls, and technical reports.
• Ensure on time delivery of API to drug product sites.

Educational Requirements:

• Bachelor's degree in biology, biochemistry, engineering or related discipline.

Experience Requirements:

• Relevant foundational experiences in technical services, process engineering, quality assurance or process development (greater than 5 years).
• The individual must have a thorough understanding of bioprocess development, regulatory requirements, cGMP, and HSE regulations.
• Leadership attributes such as communication, accountability, and interpersonal skillsets are highly desirable.
• Demonstrated ability to troubleshoot at scale processing issues, perform root cause analysis, and implement corrective and preventative actions is preferred.

Additional Information:

• The position is 8 hour days with flexibility as needed to support activities during shutdowns, weekends, etc.
• Travel is possible, but expected to be minimal

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.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.