Associate Director – Technical Services/Manufacturing Science

About the role

Lilly is currently 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.

Responsibilities

The Associate Director – TS/MS, will lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions. Key responsibilities include:

• Leading a technical organization to provide oversight of biological and bioconjugate manufacturing processes
• Supporting 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
• Leading, developing and retaining a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement
• Providing 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
• Determining TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations
• Supporting the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant
• Reviewing and approving documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports
• Supporting the project team to deliver the facility to the site lead team ready to operate and on schedule

Requirements

The basic requirements for this role include:

• 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

Skills/Preferences

Additional skills and preferences for this role include:

• 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

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including:

• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Eligibility for medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Pay

The anticipated wage for this position is $123,000 - $180,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Schedule

Role is Monday through Friday onsite. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or off-hour work may be required. Travel is possible, but expected to be minimal.