About The Position

Lilly is constructing an advanced manufacturing facility for monoclonal antibodies and bioconjugates in Goochland County, Virginia. The facility will support current and future products. This role is part of the leadership team responsible for starting up the manufacturing site and helping build the organization, facility, and culture for successful GMP manufacturing operations. The TS/MS organization, also known externally as MSAT, provides technical oversight to ensure robust and consistent biology and chemistry throughout manufacturing. It collaborates across functions to support product quality and safety through process monitoring and technical knowledge that controls, prevents, and mitigates variability. The Associate Director – TS/MS - Analytical Support will lead a technical organization providing oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations, and quality. The role supports reliable, controlled manufacturing through process monitoring and technical expertise.

Requirements

  • BS or higher in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline.
  • 10 or more years of experience in analytical development, characterization, or technical support for biologics, including monoclonal antibodies or bioconjugates.
  • At least 5 years of experience in a people leadership role.
  • Experience in analytical method development for biologic drug substance and drug product.
  • Experience supporting or authoring CMC regulatory submissions.
  • Onsite Monday through Friday in Goochland County, Virginia.
  • Flexibility to support changing operational inputs such as production schedules and shutdowns; occasional extended hours or off-hour work may be required.

Nice To Haves

  • Advanced degree (MS or PhD) in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline.
  • Experience in GMP manufacturing operations and supporting regulatory inspections and audits.
  • Knowledge of manufacturing processes, laboratory-scale models, and unit operations used in manufacturing biotech products.
  • Knowledge of laboratory-scale models and commercial-scale biotech manufacturing processes.
  • Strong written and verbal communication skills.
  • Ability to work independently and as part of a process team comprising management, production/science, and engineering professionals.
  • Ability to respond quickly and proactively to changing priorities within limited timelines.

Responsibilities

  • Support site leadership in building a diverse and capable TS/MS organization with the capability, capacity, and culture to operate the facility to high standards.
  • Lead, develop, and retain a high-performing team, fostering technical excellence, curiosity, accountability, and continuous improvement.
  • Coach, mentor, and manage the performance of direct reports, supporting their development and structuring the team for long-term success.
  • Determine TS/MS staffing and resource needs for process operations and facility startup, enabling successful process qualifications and validations.
  • Support development and implementation of robust control strategies for regulatory compliance and operational excellence using lean principles in a digitally native plant.
  • Review and approve procedures, deviation investigations, technical reports, change controls, and qualification and validation protocols and summary reports.
  • Support the project team in delivering the facility to the site lead team ready to operate and on schedule.
  • Provide technical oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations, and quality functions.

Benefits

  • Company bonus, depending in part on company and individual performance.
  • Eligibility to participate in a company-sponsored 401(k).
  • Pension.
  • Vacation benefits.
  • Eligibility for medical, dental, vision, and prescription drug benefits.
  • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
  • Life insurance and death benefits.
  • Certain time-off and leave-of-absence benefits.
  • Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
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