Director - Brd Analytical Development

Lilly

Indianapolis, IN, US
Base: $139,500 - $217,800; bonus: compyny bonus de...
Onsite
Leading analytical efforts in pharmaceutical development
Authoring ind/cta bla/nda maa regulatory submissions
Developing analytical methods and stability studies
The role involves leading drug substance and/or drug product analytical efforts within a multidisciplinary team to enable clinical trials and regulatory submissions

Job Summary

  • The role involves leading drug substance and/or drug product analytical efforts within a multidisciplinary team to enable clinical trials and regulatory submissions.
  • Candidates must possess the ability to author complex regulatory documents such as IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions.
  • 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 drug substance and/or drug product analytical efforts within a multidisciplinary team to enable clinical trials and regulatory submissions.

Salary

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

Skills & Requirements

Must-have

  • Leading analytical efforts in pharmaceutical development
  • Authoring IND/CTA BLA/NDA MAA regulatory submissions
  • Developing analytical methods and stability studies
  • Executing technology transfer to CRO CMO organizations
  • Managing technical projects and resource allocation

Nice-to-have

  • Strong communication organizational and leadership skills
  • Ability to drive and accept change
  • Demonstrated success in persuasion influence and negotiation
  • Mentoring and developing scientific staff
  • Embracing diverse thoughts and backgrounds

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
  • Experience with global regulatory strategies
  • Proven track record of technology transfer execution

Work Rights

Not specified

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