Director - TS/MS Dry Products Manufacturing and Commercialization

Eli Lilly and Company • Us, IN

14d

About The Position

The Director/Sr. Director/Executive Director, TS/MS - Dry Products Network provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. We are seeking talent at the Director through Executive Director level; the final title and scope will be aligned with the candidate’s experience, organizational impact, and leadership capabilities. Key Objectives/Deliverables Serve as Manufacturing TS/MS (Technical Services/Manufacturing Science) representative to work across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products. Leverage prior commercial manufacturing and development experience of oral solid dose forms to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement or advanced application of control strategies across sites and technologies. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Achieve network level results for Lilly’s dry products (oral solid dosage forms) that improve effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business by driving significant organizational improvement and capability work. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across manufacturing sites according to best practices and technical principles. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms including batch and continuous manufacturing operations. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Monitor and influence (as needed) external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.

Requirements

• BS, MS, and/or PhD in Chemistry, Engineering, Pharmacy, or related science with minimum 18+ years of direct experience in Oral Solid Dose Form Manufacturing and Development/Commercialization.
• A minimum of 5 years of commercial manufacturing support (after process validation) of oral solid dose (OSD) forms with ability to apply this experience to development of new OSD products.

Nice To Haves

• Evidence of deep technical expertise in 1st principles (physics, engineering, chemistry/physical chemistry) across OSD unit operations and related subjects.
• Ability to apply these effectively in the development, technical transfer, scale up/down, and trouble shooting/optimization of OSD commercial manufacturing processes.
• Ability to lead implementation of new technologies and digital capabilities to optimize manufacturing capabilities.
• Evidence of technical leadership to develop and drive organizational/technical/compliance (Regulatory/Quality) strategies as well as contribute to organizational development through mentoring and coaching.
• Excellent written and oral communication skills with ability to influence Management and broader organization.
• Flexibility to interact with multiple partners/functions, regions, and cultures.
• Ability to work well independently, as well as in teams.
• Provides partnership and collaboration across multiple disciplines.
• Ability to lead teams effectively.
• Demonstrated, strong analytical and problem-solving abilities.
• Effective at integrating multiple technology disciplines to drive programs forward.

Responsibilities

• Serve as Manufacturing TS/MS representative to work across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products.
• Leverage prior commercial manufacturing and development experience of oral solid dose forms to anticipate commercial manufacturing challenges for new dry products.
• Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs.
• Ensure that experiments and technical work are well designed and appropriately rigorous.
• Use first principles and theoretical knowledge to define scientific approaches to support technical expectations.
• Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement or advanced application of control strategies across sites and technologies.
• Serve as the Global Molecule Steward for select oral solid dosage form drug products.
• Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness.
• Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
• Achieve network level results for Lilly’s dry products (oral solid dosage forms) that improve effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business by driving significant organizational improvement and capability work.
• Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed.
• Drive appropriate shared learning, alignment and improvement across manufacturing sites according to best practices and technical principles.
• Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
• Leverage prior experience and knowledge as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms including batch and continuous manufacturing operations.
• Influence Development on new product or platform topics in line with Manufacturing needs.
• Identify and lead the deployment of other new technology as appropriate.
• Author technical reports and appropriate sections of regulatory submission and responses as needed.
• Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.
• Monitor and influence (as needed) external pharmaceutical manufacturing trends and innovations.
• Leverage these to improve strategies and applications for developing and controlling manufacturing processes.
• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation.
• As a reviewer of technical reports, provide input on the experimental findings and conclusions.
• Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree