Program Manager, CRDMO
On-siteAlameda, California, United States
Job Summary
Lead end-to-end cell and gene therapy CRDMO programs within an Integrated Project Delivery framework, co-owning outcomes with Synthetic Biology, Process Development, and GMP Manufacturing teams. Facilitate Joint Steering Committee meetings, drive escalation to governance committees, and manage scope, deliverables, and budget forecasts using IPD cost-transparency practices. Translate technical data into program decisions for IND, IMPD, and BLA submissions while serving as the primary point of contact for sponsors and clients. Identify and mitigate technical, regulatory, and timeline risks through scenario-based mitigation strategies and resource advocacy.
Required Qualifications
- Bachelor's degree in Life Sciences, Bioengineering, Chemical Engineering, or related field
- 5–8+ years of CMC program management experience in biotech, pharma, or cell and gene therapy across the full CMC lifecycle
- Experience supporting IP, IND, BLA, MAA, or IMPD submissions
- Demonstrated experience leading programs in an IPD, alliance management, or co-development model
- Track record leading cross-functional product development projects (SynBio, PD, AD, MSAT, MFG, QC)
Desired Qualifications
- advanced degree (MBA/M.S./Ph.D.)
- CRDMO/sponsor partnership experience
- PMP certification, IPD, Lean, or Alliance Management training
- Proficiency with Smartsheet Advance, ThinkCell, and integrated scheduling platforms
- strong quantitative, risk modeling, and KPI design skills
- Proven ability to lead without direct authority in a matrixed, shared-accountability environment
- excellent communication, facilitation, and negotiation skills
- High adaptability and emotional intelligence
- comfortable with fast-paced, distributed, cross-functional settings
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