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Associate Director - TS/MS - Lebanon API

Eli Lilly and Company
On-site
Lebanon, IN
$123,000 - $180,400 USD yearly
Operations

Role Summary

The Associate Director – Technical Services/Manufacturing Science (TSMS) leads TSMS personnel and shapes the technical agenda to support GMP manufacturing operations. The role balances coaching a technical staff, prioritization for organizational build, and execution of technical projects and process optimizations. It requires cross-functional collaboration within the site and network to meet technical objectives, product plans, and quality goals, with startup activities for the Lebanon API site planned from 2025 to 2027.

Responsibilities

  • Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, and technical studies.
  • Complete formal Performance Management and development of staff; provide coaching and direction to team members.
  • Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
  • Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
  • Define strategic direction and oversight for setting the technical agenda to improve process control, yield, and productivity.
  • Ensure adequate oversight and technical excellence for investigations and complaints.
  • Ensure adequate oversight for technical projects to improve process control, capacity, yield, and quality.
  • Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
  • Network globally to share best practices, rationale, and control strategies to harmonize and align between sites.
  • Engage with Pharmaceutical Product Development groups for applicable technical transfer deliverables during commercialization stages.

Responsibilities (Startup Phase – Lebanon API Site)

  • Build the organization with the necessary capability, capacity, and culture to operate this facility to high standards of operational excellence.
  • Develop and implement systems and processes to run the site, leveraging Lilly knowledge while incorporating external experiences where needed.
  • Ensure regulatory compliance and operational excellence by supporting lean principles in their area.
  • Support the project team by providing feedback and assistance to deliver the facility to the site team.

Qualifications

  • Required: Bachelor’s Degree in Chemistry, Biology, Pharmacy, Engineering or related field.
  • Required: 5+ years of experience in TSMS within a pharmaceutical manufacturing environment.
  • Required: 2+ years of experience leading teams.

Additional Preferences

  • Preferred: Ability to work with a team, make independent decisions, and influence diverse groups.
  • Preferred: Ability to foster teamwork within the department and demonstrate strong interpersonal skills.
  • Preferred: Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage cross-functional ideas.
  • Preferred: Demonstrated project management skills and ability to coordinate complex projects.