---
title: 'Program Manager, CRDMO at GeneFab'
canonical: 'https://feeny.ai/job/program-manager-crdmo-genefab-alameda-fw0njn9asgrp'
type: 'job'
last_seen: '2026-09-11'
---

# Program Manager, CRDMO at GeneFab

- **Company:** GeneFab
- **Location:** Alameda, CA
- **Compensation:** $140k–$200k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-08-11
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/genefab/abb0a708-3738-4acd-baca-5125146322a9

## Job description

We are seeking a Program Manager 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.

Key Responsibilities: IPD Program Leadership & Governance

- 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.

Key Responsibilities: Project Execution (Customer oriented and internal R&D)

- 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.

## Qualifications

- 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.

## About GeneFab

## Company Overview
- **One-liner**: GeneFab is a contract development and manufacturing organization (CDMO) that provides integrated synthetic biology, viral vector production, and cell therapy manufacturing services to innovators in the cell and gene therapy space.
- **Entity Type**: Private (funding stage not publicly available)
- **Headquarters**: Alameda, California, USA (cGMP manufacturing); additionally a SynBio Center of Excellence in South San Francisco, California, USA
- **Founded**: 2023
- **Founders**: Not publicly disclosed; key leadership includes Philip Lee (CEO) and Drew Johnston (President & COO)

## Core Business
- **Primary industry/industries**: Cell and gene therapy CDMO, synthetic biology, viral vector manufacturing, cell therapy contract manufacturing
- **Target customers**: Biotech and pharmaceutical companies developing cell and gene therapies (ex-vivo and in-vivo modalities) – primarily B2B serving innovators from research through commercial supply
- **Mission or purpose statement**: "To make innovative genetic medicines available for all."

## Products & Services
- **Ex Vivo Cell Therapy**: End-to-end autologous and allogeneic workflows covering CAR-T, TCR-T, CAR-NK, Treg, iPSC among others, with multiple expansion platforms tuned to the modality.
- **In Vivo Cell Therapy**: Optimization of genetic elements (e.g., cell-specific promoters) and manufacturing of the lentiviral vector that delivers the therapy directly to patients without an ex-vivo step.
- **Viral Vectors**: Production of lentivirus (LVV) and gamma-retrovirus (GRV) from adherent (2-20 L) to suspension GMP (50-200 L) scale, using stable producer lines.
- **Synthetic Biology**: Proprietary building blocks including cell-specific promoters, kill switches, custom producer cell lines, and ML-driven sequence design.
- **cGMP Manufacturing**: 42,000 sq ft purpose-built cGMP facility in Alameda with seven ISO 7 / Grade B suites, expandable to 92,000 sq ft, meeting FDA & EU GMP standards.
- **QC & Release**: In-house qualified methods running on a regular cadence for phase-appropriate quality release in days.
- **Process Development & Analytics**: Method development, qualification, and transfer; includes genetic circuit design, payload optimization, and analytical assay support.
- **Commercial Readiness & Supply**: Process performance qualification, BLA-readiness, and capacity to scale from clinical lots to commercial demand without changing partners.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed
- **Key Metric**: 42,000 sq ft cGMP facility (opened 2023, expandable to 92,000 sq ft) with seven suites; implementing fully electronic quality and document control systems across 2026–2027 for BLA-readiness
- **Notable Investors/Partners**: Not publicly available
- **Growth Signals**: Active hiring via Lever portal (roles include bioprocess specialist, senior manufacturing engineer, program manager, regulatory programs specialist, quality control analyst); leadership team has experience scaling programs from research to commercial supply across multiple modalities

## Competitive Advantages
- **Modality-agnostic design**: Built to handle the full breadth of cell and gene therapy fields – ex-vivo, in-vivo, viral vectors, and synthetic biology – all under one roof.
- **Integrated platform**: Offers one continuous handoff from genetic design and R&D through IND-enabling, clinical, and commercial supply, minimizing vendor handoffs.
- **Co-development approach**: Positions itself as a co-development team with deep innovator-side experience rather than a transactional vendor.
- **New purpose-built facility**: Brand-new 2023 cGMP facility designed specifically for cell and gene therapy, with validated equipment and modern aseptic processing.
- **Leadership track record**: Senior leadership has commercial-scale experience and a clear roadmap to take partner programs through clinical trials and BLA.

## Strategic Focus
- Expanding cGMP manufacturing capacity (future 92K sq ft) to support commercial supply.
- Implementing digital quality systems (2026–2027) to achieve FDA pre-approval inspection readiness.
- Continuing to build a team of scientists, engineers, and operators to support partner programs from early-stage through commercial launch.

## Why Work Here
- **Culture**: Mission-driven environment focused on bringing breakthrough cell and gene therapies to patients. Described as "a team of scientists, engineers, and operators building the CDMO we always wished existed."
- **Work policy**: All listed current openings are on-site in Alameda, CA; some roles operate on 4x10 shift schedules.
- **Growth opportunity**: Join a young CDMO (founded 2023) with ambitions to scale from clinical to commercial supply, offering potential for career advancement as the company expands.
- **State-of-the-art facility**: Work in a new, purpose-built cGMP facility with modern equipment and cleanrooms.
- **Impact**: Directly contribute to the development and manufacturing of life-changing genetic medicines.

## Sources
1. [genefab.com](https://www.genefab.com/)
2. [genefab.com/about](https://www.genefab.com/about.html)
3. [genefab.com/careers](https://www.genefab.com/careers.html)
4. [genefab.com/team](https://www.genefab.com/team.html)
5. [jobs.lever.co/genefab](https://jobs.lever.co/genefab)

## Other roles at GeneFab

- [Senior Specialist, Regulatory Programs (Part-Time)](https://feeny.ai/job/senior-specialist-regulatory-programs-part-time-genefab-alameda-wjq5195mkaqg) — Alameda, CA
- [Senior Analyst, Quality Control Analytical](https://feeny.ai/job/senior-analyst-quality-control-analytical-genefab-alameda-ztpns2g1kxer) — Alameda, CA
- [Senior Manufacturing Engineer](https://feeny.ai/job/senior-manufacturing-engineer-genefab-alameda-6zbjev6nm675) — Alameda, CA
- [Bioprocess Specialist - CONTRACT](https://feeny.ai/job/bioprocess-specialist-contract-genefab-alameda-svf09yk8b26f) — Alameda, CA