Advisor - Ts/ms Lab - Lebanon API Manufacturing

Eli Lilly Eli Lilly · Pharma · Lebanon, IN

This role is for an Advisor in Technical Services and Manufacturing Science (TSMS) within a pharmaceutical API manufacturing facility. The focus is on laboratory operations, process development, analytical expertise, and ensuring compliance with cGMP regulations. It involves experimental design, data analysis, troubleshooting, and mentoring. The role requires expertise in small molecule and peptide manufacturing, advanced analytical techniques, and regulatory knowledge.

What you'd actually do

  1. Develop laboratory process and analytical expertise, provide technical oversight and stewardship for small molecule and peptide manufacturing
  2. Design, oversee, and perform complex laboratory experiments, data analysis, and interpretation to support process development, characterization, and optimization.
  3. Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and research and development teams to resolve technical challenges and drive continuous improvement.
  4. Provide scientific and technical leadership for troubleshooting activities related to manufacturing deviations and out-of-specification results.
  5. Active role in mentoring and developing fellow TSMS laboratory scientists to facilitate tech transfer

Skills

Required

  • Master's or Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline
  • 5+ years of relevant experience (Master's) or 2+ years (Ph.D.) in pharmaceutical/biotechnology lab
  • Expertise in small-scale peptide and/or small molecule process development and scale-up
  • Hands-on experience with HPLC, GC, LC-MS, GC-MS, spectroscopy (UV-Vis, FTIR), and dissolution testing
  • Strong understanding of cGMP regulations, ICH guidelines, and pharmacopeial requirements (USP, EP, JP)

Nice to have

  • Proficiency in method development, validation, and transfer
  • Experience with LIMS and CDS
  • Excellent problem-solving, critical thinking, and data analysis skills
  • Strong written and verbal communication skills
  • Ability to work independently and as part of a cross-functional team
  • Proven leadership abilities and experience mentoring junior staff

What the JD emphasized

  • cGMP regulations
  • FDA
  • ICH
  • small molecule and peptide manufacturing
  • analytical techniques