2d ago

Director Chemical (Drug Substance) Manufacturing Management

Brisbane, CA

$212.8k-$262.8k / year

full-timedirector Hybridbiotech

💼 About This Role

You'll lead drug substance manufacturing for small molecule and oligonucleotide programs in a cGMP environment. You'll oversee CMO partnerships and cross-functional CMC teams to deliver reliable clinical and commercial supply. This role offers the opportunity to shape departmental strategies at a rare disease-focused biopharma.

🎯 What You'll Do

  • Lead drug substance manufacturing for synthetic molecules and oligonucleotides.
  • Oversee production planning, execution, and performance tracking.
  • Manage CMO relationships including selection and governance.
  • Author CMC sections for global regulatory filings.
  • Drive process development, optimization, and technology transfer.

📋 Requirements

  • Ph.D. in chemistry, chemical engineering, or related discipline.
  • 8–12 years of pharmaceutical experience with CMC and manufacturing.
  • Experience managing small molecule synthetic chemistry and cGMP manufacturing.
  • Demonstrated experience managing cross-functional CMC teams.

✨ Nice to Have

  • Experience with oligonucleotides.
  • Familiarity with QbD, DoE, and phase-appropriate controls.
  • Analytical development knowledge.

🎁 Benefits & Perks

  • 🏖️ Generous vacation time and public holidays
  • 💡 Annual bonus and equity incentives
  • 💼 Long term incentive and Employee stock
  • 🤝 Volunteer days

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

  1. 1Recruiter screen· 30 min
  2. 2Hiring manager interview· 1 hour
  3. 3Panel interview· 1.5 hours
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