CMC Program Lead, Cell & Gene Therapy

GeneFab; Alameda (CA); On-site; USD 175,000 - 200,000; Full time

Job summary

GeneFab seeks a Program Manager to drive cell and gene therapy CRDMO programs within an IPD framework, supporting the full product development lifecycle from design to regulatory submission.

You will lead cross-functional teams, co-own outcomes with sponsors and partners, and ensure transparency, risk surfacing, and joint decision-making across IPT governance. This role requires deep technical expertise and collaborative leadership in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 5–8+ years in CMC program management in biotech/pharma.
• IPD or alliance management experience preferred.
• PMP, IPD or Lean training is a plus.

Responsibilities

• Lead end-to-end program execution across design, development, and regulatory submission.
• Coordinate cross-functional teams (SynBio, PD, AD, MSAT, QC, MFG).
• Own CMC content roadmap and IND/MAA submission readiness.
• Embed IPD principles and manage budgets, risk, and invoicing.
• Serve as primary contact for sponsors and integrate third-party partners.

Skills

Program management

Cross-functional leadership

IPD/Alliance management

Stakeholder communication

Risk management

Education

Bachelor’s degree in Life Sciences

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, supporting the full product development lifecycle from design to regulatory submission.

You will lead cross-functional teams, co-own outcomes with sponsors and partners, and ensure transparency, risk surfacing, and joint decision-making across IPT governance. This role requires deep technical expertise and collaborative leadership in a fast-paced biotech environment.