Director/Sr Director/Executive Director - TS/MS - Dry Products Network

Eli Lilly and • Indianapolis, IN

331d

About The Position

Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. The role involves serving as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products. The candidate will leverage prior experience to anticipate commercial manufacturing challenges for new dry products and work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Additionally, the role includes serving as the Global Molecule Steward for select oral solid dosage form drug products, integrating different disciplines such as engineering and analytical science on technical projects, and providing proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.

Requirements

• Technical expertise in multiple areas, unit operations, and platforms related to technical support of dry products (oral solid dosage forms) commercial manufacturing.
• Bachelor's Degree or Masters in Chemistry, Engineering, Pharmacy, or related science with minimum of 15-20 years of direct experience in Dry products Manufacturing and Development/Commercialization.
• PhD in Chemistry, Engineering, Pharmacy, or related science with minimum of 10 years of direct experience in Dry products Manufacturing and Development/Commercialization is preferred.

Nice To Haves

• Flexibility to interact with multiple partners/functions, regions, and cultures.
• Demonstrated, strong technical leadership and communication skills.
• Ability to work well independently, as well as in teams.
• 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 with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products.
• Leverage prior experience 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.
• 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.
• Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
• Achieve network level results for Lilly's dry products that improve effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business.
• Drive significant organizational improvement and capability work.
• Influence global leadership in driving improvements and resolving issues.
• Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites.
• Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles.
• Ensure that experiments and technical work are well designed and appropriately rigorous.
• Utilize in depth understanding of materials, process, and product to improve product/process robustness.
• Collaborate with Project Managers on key product project plans and support timely delivery of milestones.
• Leverage prior experience and knowledge as a recognized Subject Matter Expert.
• 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.
• Remain current on external pharmaceutical manufacturing trends and innovations.
• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation.
• Mentor and provide review/coaching to develop other technical resources.

What This Job Offers

• Industry: Chemical Manufacturing