Associate Director – Technical Services/Manufacturing Science
About The Position
Lilly is constructing an advanced manufacturing facility for monoclonal antibodies and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a 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. The TS/MS organization, also known externally as MSAT (Manufacturing Science and Technology) provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of the manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine.
Requirements
- BS, MS, or PhD in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline, with 5+ years of experience in the biopharmaceutical industry.
- Minimum of 3+ years in a people leadership role.
- Experience in GMP manufacturing operations and supporting regulatory inspections and audits.
Nice To Haves
- Advanced degree (MS or PhD) in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline preferred.
- Knowledge of manufacturing processes, lab scale models, and unit operations used in the manufacturing of biotech products.
- Knowledge of laboratory scale models and commercial scale biotech manufacturing processes.
- Strong written and verbal communication skills.
- Ability to work on own initiative and as part of a process team consisting of a diverse group of management, production/science and engineering professionals.
- Ability to respond quickly and proactively to changing priorities within a limited timeline.
Responsibilities
- Lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions.
- Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence.
- Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement.
- Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential and the team is structured for long-term success.
- Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations.
- Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant.
- Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports.
- Support the project team to deliver the facility to the site lead team ready to operate and on schedule.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Manager
