Sr. Manager / Associate Director, Drug Substance; Hypopara

Bridgebio

San Francisco, California, United States
Market leading compensation; 401k with 100% employ...
On-site
Managing cmos and cros
Process validation and commercial manufacturing
Synthetic organic chemistry expertise
The role involves managing outsourced drug substance process development and manufacturing activities at contract suppliers to support clinical studies and commercial launch

Job Summary

  • The role involves managing outsourced drug substance process development and manufacturing activities at contract suppliers to support clinical studies and commercial launch.
  • Candidates must demonstrate deep chemical development experience at industrial scale along with strong aptitude in synthetic organic chemistry.
  • BridgeBio offers comprehensive health care with 100% premiums covered, unlimited flexible paid time off, and a hybrid work model.

Matching Summary

The role involves managing outsourced drug substance process development and manufacturing activities at contract suppliers to support clinical studies and commercial launch.

Salary

Market leading compensation; 401K with 100% employer match on first 3% & 50% on next 2%; Employee stock purchase program

Skills & Requirements

Must-have

  • Managing CMOs and CROs
  • Process validation and commercial manufacturing
  • Synthetic organic chemistry expertise
  • cGMP and regulatory compliance knowledge
  • Module 3 CTD authorship experience

Nice-to-have

  • Culture of continuous improvement
  • Ability to defy convention
  • Ethical use of AI in work
  • Strong attention to detail
  • Independent team player

Key Requirements

  • PhD in Chemistry or Chemical Engineering with 7+ years experience
  • BS/MS with 10+ years relevant experience
  • Experience with FDA and ICH guidelines for INDs/NDAs/MAAs
  • Up to 20% travel required

Work Rights

Not specified

Tailored Resume

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