Principal Scientist

We are seeking a highly skilled and experienced professional to provide technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network.

• Technical Leadership: 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.
• Process Optimization: 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.
• Global Molecule Stewardship: Serve as the Global Molecule Steward for select oral solid dosage form drug products and collaborate with different disciplines such as engineering and analytical science on technical projects.
• Data Analysis and Reporting: Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
• Manufacturing Process Transfers: Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites and additional technical support/guidance for external manufacturing as needed.
• Shared Learning and Improvement: Drive shared learning, alignment, and improvement across sites and network level activity according to best practices and technical principles.
• Experiment Design and Execution: Ensure that experiments and technical work are well designed and appropriately rigorous.
• Process Improvement: Utilize in-depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies.
• Project Management Support: Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
• Subject Matter Expertise: Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms.
• Regulatory and Quality Support: Author technical reports and appropriate sections of regulatory submission and responses as needed.
• Regulatory and Quality Reviews: Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.
• Industry Trends and Innovations: Remain current on external pharmaceutical manufacturing trends and innovations and leverage these to improve strategies and applications for developing and controlling manufacturing processes.
• Study Design and Protocol Development: Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation.
• Mentorship and Coaching: Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.

• Education: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science.
• Experience: Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing.

• Technical Leadership and Communication Skills: Demonstrated, strong technical leadership and communication skills.
• Collaboration and Partnership: Ability to work well independently, as well as in teams, and provide partnership and collaboration across multiple disciplines.
• Analytical and Problem-Solving Skills: Demonstrated, strong analytical and problem-solving abilities.
• Integration of Multiple Disciplines: Effective at integrating multiple technology disciplines to drive programs forward.
• Cultural Competence: Flexibility to interact with multiple partners/functions, regions, and cultures.