Director, Biologics Cmc/dct Leader

Mericalherbs

Base: $173,200.00 - $272,600.00; bonus/equity: ann...
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Biologics cmc development strategy
End-to-end execution of dct deliverables
Robust processes and analytics
** Mericalherbs is seeking a Director, Biologics CMC/DCT Leader to oversee the integrated development and commercialization of their biologics portfolio. The ideal candidate will have extensive experience in CMC processes, strong leadership skills, and the ability to navigate complex regulatory environments to achieve successful product launches. **

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 salary range for this role is $173,200.00 - $272,600.00, and the successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Matching Summary

Match Score: 75

** Mericalherbs is seeking a Director, Biologics CMC/DCT Leader to oversee the integrated development and commercialization of their biologics portfolio. The ideal candidate will have extensive experience in CMC processes, strong leadership skills, and the ability to navigate complex regulatory environments to achieve successful product launches. **

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 (for employee and family), 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
  • Resiliency within the team

Key Requirements

  • 15 years relevant experience with BS
  • 12 years relevant experience with MS
  • 10 years relevant experience with PhD
  • Cross divisional networking skills
  • Functional and enterprise leadership
  • Ability to influence at all levels
  • Strong collaborative skills
  • Product management systems and tools
  • Business and financial skills
  • Manage multiple programs
  • US and Puerto Rico Residents Only

Work Rights

Not specified

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