Director Product Development
Technical Operations - Remote or San Diego, California (Hybrid)
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
POSITION SUMMARY:
The position is responsible for the project oriented technical leadership for process development and manufacturing of investigational drug products from clinical to commercial stage.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manage and oversee activities and contractual relationship with Contract Manufacturing Organizations (CMOs) performing process scale-up development, technology transfer, and manufacturing of drug product.
- Lead and collaborate with cross functional project team members to meet operational, quality, and CMC goals.
- Write Request for Proposal and negotiate contracts and agreements. Evaluate and select contract manufacturers.
- Thoroughly review and approve master and executed manufacturing and packaging batch records.
- Provide manufacturing summary reports.
- Assist in preparation of regulatory documentation for IND and NDA submissions.
- Work closely with CMC project managers, CTM supply chain manager, and drug substance team to plan and coordinate manufacturing activities to meet clinical supply projection.
- Troubleshoot manufacturing related issues. Make decisions and recommendations.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
- Master’s degree in pharmaceutical sciences, chemistry, chemical engineering or relevant area.
- 8+ years relevant industry experience with increasing responsibility.
- Extensive experience with process scale-up and manufacturing of oral solid dosage forms.
- Prior experience with QbD (Quality by Design) and process validation is a plus.
- Proven track record of CMO management.
- Experience in compiling technical information for manufacturing and control of critical steps to support regulatory submissions.
- Thorough understanding of drug product GMPs and quality systems.
- Excellent written and oral communication skills.
- Strong organizational and problem solving skills.
- Willing to travel up to 30% of time.
