Advisor/ Sr. Advisor – Small Molecule Process Development

Eli Lilly Eli Lilly · Pharma · Hyderabad, India

This role focuses on the process development and optimization of small molecule drug substance manufacturing within the pharmaceutical industry. It involves technical transfers, ensuring processes are robust and cost-effective, and collaborating with R&D and plant sites. The position requires a strong understanding of GMP, regulatory requirements, and the ability to lead technical projects and mentor junior staff. Experience with digitization and regulatory interactions is also highlighted.

What you'd actually do

  1. Work in the ab along with the team towards process development of manufacturing processes
  2. Leverage internal and external expertise to improve existing production processes
  3. Establish a world class methodology to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into production
  4. Lead the successful transfer of new processes or steps into production across the globe
  5. Maintain a thorough understanding of the state of the art of manufacturing and regulatory requirements and build these into our processes

Skills

Required

  • Ph.D. in Organic Chemistry/Chemistry
  • Process chemistry expertise
  • Pharmaceutical industry knowledge
  • Good Manufacturing Practices (GMP)
  • Regulatory requirements understanding
  • Process optimization
  • Technical transfer experience
  • Project leadership
  • Mentoring skills
  • Digitization and digital tools deployment
  • Regulatory interaction experience

Nice to have

  • Post Doc in Chemistry
  • Experience with peptides
  • Understanding of drug substance and drug product formulation interaction

What the JD emphasized

  • proven track record of driving technical agendas
  • proven track record in the following areas
  • Demonstrated ability to commercialize and solve manufacturing problems
  • Hands on experience supporting production at different scales
  • Proven track record of working with diverse groups
  • Significant experience with registration
  • Proven record of embracing advanced digitization efforts