Director, Biologics Cmc/dct Leader

29

Base: $173,200.00 - $272,600.00; bonus/equity: ann...
**
Biologics cmc development strategy
End-to-end execution of dct deliverables
Robust processes and analytics
** The position of Director, Biologics CMC/DCT Leader is focused on overseeing the development and commercialization strategy for biologics at a leading pharmaceutical company. The role requires extensive experience in CMC processes, strong leadership abilities, and a collaborative mindset to ensure successful product outcomes and adherence to regulatory standards. **

Job Summary

  • The DCT leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product.
  • Responsible for on-time, end-to-end execution of DCT deliverables including – robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve uninterrupted long-term supply.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits, retirement benefits, paid holidays, vacation, and compassionate and sick days.

Matching Summary

Match Score: 75

** The position of Director, Biologics CMC/DCT Leader is focused on overseeing the development and commercialization strategy for biologics at a leading pharmaceutical company. The role requires extensive experience in CMC processes, strong leadership abilities, and a collaborative mindset to ensure successful product outcomes and adherence to regulatory standards. **

Salary

Base: $173,200.00 - $272,600.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • Biologics CMC development strategy
  • End-to-end execution of DCT deliverables
  • Robust processes and analytics
  • Integrated control strategy
  • Successful tech transfer packages
  • Commercial supply chain
  • cGMP compliance

Nice-to-have

  • Fosters a learning and collaborative environment
  • Innovative solutions to unforeseen circumstances
  • Customer orientation
  • Growth mindset
  • Active listening
  • High performing teams
  • Resiliency within the team

Key Requirements

  • 15 years relevant experience with BS
  • 12 years relevant experience with MS
  • 10 years relevant experience with PhD
  • Strong cross divisional networking skills
  • Functional and enterprise leadership
  • Ability to influence at all levels
  • Strong collaborative skills
  • Strong understanding of product management systems
  • Strong business and financial skills
  • Ability to manage multiple programs
  • Experience in mAb development and commercialization
  • Experience in Technical product stewardship
  • Successfully commercializing large molecule programs
  • Expert knowledge in global regulatory requirements
  • Expert knowledge in QbD

Work Rights

Not specified

Tailored Resume

Cover Letter