Director - Brd Analytical Development

Liljamesofficial

Indianapolis, IN, US
Base: $139,500 - $217,800; bonus: compyny bonus de...
Onsite
Phd in analytical chemistry required
Leading analytical efforts for drug substance
Authoring ind/cta and bla/nda/maa submissions
The role involves leading analytical efforts to enable clinical trials, regulatory submissions, and new product commercialization within a multidisciplinary team

Job Summary

  • The role involves leading analytical efforts to enable clinical trials, regulatory submissions, and new product commercialization within a multidisciplinary team.
  • Candidates must possess deep knowledge of drug substance and product commercialization concepts, including developing analytical methods and justifying specifications.
  • Lilly offers a comprehensive benefit program including medical, dental, vision, 401(k), pension, and well-being benefits alongside a competitive salary range.

Matching Summary

The role involves leading analytical efforts to enable clinical trials, regulatory submissions, and new product commercialization within a multidisciplinary team.

Salary

Base: $139,500 - $217,800; Bonus: Company bonus depending on performance; Benefits: Medical, dental, vision, 401(k), pension, vacation

Skills & Requirements

Must-have

  • PhD in Analytical Chemistry required
  • Leading analytical efforts for drug substance
  • Authoring IND/CTA and BLA/NDA/MAA submissions
  • Experience with global regulatory strategies
  • Executing technology transfer to CRO/CMO
  • Developing control strategies for modalities

Nice-to-have

  • Strong communication and leadership skills
  • Ability to drive and accept change
  • Demonstrated success in persuasion and negotiation
  • Mentoring and developing scientific staff
  • Influence others to promote positive work environment

Key Requirements

  • Ph.D. in Analytical Chemistry with 5+ years experience
  • B.S. in Chemistry with 15+ years experience
  • M.S. in Chemistry with 10+ years experience
  • Prior experience leading pharmaceutical analytical efforts
  • Experience authoring regulatory responses (RtQ)

Work Rights

Not specified

Tailored Resume

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