Full Job Description
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.
Job Title: Associate Director - Technical Services/Manufacturing Science (TS/MS / MSAT) - Bioconjugate/Drug Product Manufacturing
Organization Overview:
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.
Responsibilities:
The Associate Director - TS/MS - Bioconjugate/Drug Product Manufacturing, will lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions. TS/MS is responsible for ensuring manufacturing processes run reliably in state control through process monitoring supported through technical knowledge.
37 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
37 Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement
37 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
37 Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations
37 Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant
37 Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports
37 Support the project team to deliver the facility to the site lead team ready to operate and on schedule
Basic Requirements:
37 BS, MS, or PhD in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline, with 5+ years of experience in the biopharmaceutical industry
37 Minimum of 3+ years in a people leadership role
37 Experience in GMP manufacturing operations and supporting regulatory inspections and audits
37 Experience in biological drug product manufacturing, with deep expertise in lyophilization process development and optimization
Additional Skills/Preferences:
37 Advanced degree (MS or PhD) in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline preferred
37 Knowledge of manufacturing processes, lab scale models, and unit operations used in the manufacturing of biotech products
37 Knowledge of laboratory scale models and commercial scale biotech manufacturing processes
37 Strong written and verbal communication skills
37 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
37 Ability to respond quickly and proactively to changing priorities within a limited timeline
Additional Information:
37 Travel is possible, but expected to be minimal
37 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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. 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). In addition, 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.