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