Senior Technical Lead

2 weeks ago


Marquand, Missouri, United States Eli Lilly Full time
Job Summary

We are seeking a highly skilled and experienced Principal Scientist to provide technical leadership for dry product manufacturing processes under development and in commercial production in the Dry Product Network at Eli Lilly.

Key Responsibilities:
  • 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 Development: 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 Conclusion: 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: Ensure that experiments and technical work are well designed and appropriately rigorous.
  • Process Optimization: Utilize in-depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies.
  • Project Management: 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 Reviews and Inspections: 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: 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.
Requirements:
  • 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.
Preferred Qualifications:
  • Technical Leadership and Communication: 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 Abilities: Demonstrated, strong analytical and problem-solving abilities.
  • Integration of Technology Disciplines: Effective at integrating multiple technology disciplines to drive programs forward.
  • Cultural Competence: Flexibility to interact with multiple partners/functions, regions, and cultures.


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