IPD Biotech Program Lead: CMC & Regulatory Strategy

GeneFab; Alameda (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

GeneFab seeks a Program Manager to drive cell and gene therapy CRDMO programs within an IPD framework. You will co-own outcomes with sponsors, internal partners, and external parties, leading cross-functional IPT workstreams and governance to ensure transparent decisions and on-time delivery.

You will manage end-to-end program execution from design through regulatory submission, balancing technical rigor with stakeholder alignment and risk management, in a fast-paced biotech environment.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5–8+ years of CMC program management experience in biotech, pharma, or cell and gene therapy.
• Experience leading IPD/co-development models and alliance management.
• Proficiency with Smartsheet Advance, ThinkCell, and scheduling platforms.

Responsibilities

• Lead end-to-end program execution across design, development, readiness, qualification, and regulatory submission.
• Coordinate cross-functional workstreams (SynBio, PD, AD, MSAT, QC, MFG) for data integrity and compliance.
• Translate data into program decisions with traceability to TPPs, CQAs, CPPs, and regulatory expectations.
• Oversee knowledge transfer, tech transfer from PD to GMP Manufacturing, and sponsor/client handoffs.

Skills

Program management

IPD leadership

Cross-functional leadership

Regulatory awareness

PMO & risk management

Education

Bachelor's degree in Life Sciences or related field

MBA/Ph.D. (nice to have)

Tools

Smartsheet Advance

ThinkCell

Scheduling platforms

Job description

GeneFab seeks a Program Manager to drive cell and gene therapy CRDMO programs within an IPD framework. You will co-own outcomes with sponsors, internal partners, and external parties, leading cross-functional IPT workstreams and governance to ensure transparent decisions and on-time delivery.

You will manage end-to-end program execution from design through regulatory submission, balancing technical rigor with stakeholder alignment and risk management, in a fast-paced biotech environment.