What are the responsibilities and job description for the CRDMO Program Lead position at GeneFab?
We are seeking a Program Lead to drive cell and gene therapy Contract Research, Development, and Manufacturing Organization (CRDMO) programs within an Integrated Project Delivery (IPD) framework. This role supports the full product development lifecycle — from biological design and process development through pivotal manufacturing and regulatory submission — operating as a shared-accountability leader embedded within a unified, cross-functional project team. The ideal candidate brings deep technical expertise, a collaborative leadership style, and the agility to co-own outcomes with sponsors, internal partners, and external parties under IPD principles of transparency, early risk surfacing, and joint decision-making.
\n- Lead the workstream within the Integrated Project Team (IPT), co-owning program outcomes with Synthetic Biology, Process Development, Analytical Development, MSAT, Quality Control, GMP Manufacturing, Regulatory Affairs, Finance and sponsor partners.
- Facilitate IPT working sessions and Joint Steering Committee (JSC) meetings; frame decisions with full context, scenario analysis, and downstream impact.
- Champion IPD principles: shared risk/reward, open-book collaboration, and joint decision-making across all workstreams.
- Drive escalation to governance committees at the right level and time; iterate on PMO frameworks, risk registers, and project review boards to improve oversight.
- Lead end-to-end program execution, including therapeutic design, process and analytical development, pivotal readiness, method qualification/validation, pilot & engineering run strategies, and regulatory submission readiness.
- Drive cross-functional alignment across SynBio, PD, AD, MSAT, QC, and GMP Manufacturing to ensure process consistency, data integrity, and regulatory compliance.
- Translate technical data into program decisions with clear traceability to TPPs, CQAs, CPPs, and regulatory expectations.
- Orchestrate knowledge transfer at key project stages, including onboarding new intellectual property, technology transfer from PD to GMP Manufacturing, and handoffs between customers and internal teams and third party partners in real time.
- Co-lead CMC regulatory strategy with Regulatory Affairs; own the CMC content roadmap and ensure data packages are submission-ready for IND, IMPD, BLA/MAA, or applicable filings.
- Serve as primary point of contact for sponsors and clients; lead integration sessions that bring sponsor teams into the delivery process as active IPD participants.
- Manage scope, deliverables, and expectations, lead change order and scope modification discussions in collaboration with Business Development and technical leads.
- Track program budgets, resource forecasts, and milestone-based invoicing using IPD cost-transparency practices for real-time financial visibility.
- Identify, quantify, and manage technical, regulatory, and timeline risks; develop scenario-based mitigation strategies and advocate for resources (personnel, equipment, capacity) as needed.
- Bachelor’s degree (required) in Life Sciences, Bioengineering, Chemical Engineering, or related field; advanced degree (MBA/M.S./Ph.D.) is nice to have.
- 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; CRDMO/sponsor partnership experience strongly preferred.
- Track record leading cross-functional product development projects (SynBio, PD, AD, MSAT, MFG, QC,)
- PMP certification, IPD, Lean, or Alliance Management training a plus.
- 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.
About GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.
We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
Salary : $175,000 - $215,000