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Genefab Jobs in California (NOW HIRING)

GeneFab

Advanced Therapies CMC Program Manager

Alameda, CA · On-site

$175K - $200K/yr

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 ...

GeneFab

Senior Process Engineer, MSAT

Alameda, CA · On-site

$117K - $152K/yr

GeneFab is seeking a highly motivated and technically accomplished Senior Process Engineer, MSAT to serve as a critical technical authority within our Cell and Gene Therapy CDMO. This individual will ...

GeneFab

Senior Process Engineer, MSAT

Alameda, CA

$117K - $152K/yr

GeneFab is seeking a highly motivated and technically accomplished Senior Process Engineer, MSAT to serve as a critical technical authority within our Cell and Gene Therapy CDMO. This individual will ...

GeneFab

Senior Process Engineer, MSAT

Alameda, CA · On-site

$72 - $89/hr

GeneFab is seeking a highly motivated and technically accomplished Senior Process Engineer, MSAT to serve as a critical technical authority within our Cell and Gene Therapy CDMO. This individual will ...

GeneFab

Sr. Manager/Manager, Manufacturing

Alameda, CA

$140K - $180K/yr

GeneFab is seeking an experienced and highly motivated Sr. Manager / Manager, Manufacturing to lead and oversee cGMP manufacturing operations for our Cell and Gene Therapy CDMO. This position carries ...

GeneFab

Sr. Manager/Manager, Manufacturing

Alameda, CA · On-site

GeneFab is seeking an experienced and highly motivated Sr. Manager / Manager, Manufacturing to lead and oversee cGMP manufacturing operations for our Cell and Gene Therapy CDMO. This position carries ...

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Genefab information

How does GeneFab work?

GeneFab is a biotechnology company that specializes in gene synthesis and DNA manufacturing services. The process involves designing genetic sequences, synthesizing DNA strands in a laboratory, and delivering the products to clients, often using specialized tools and quality control measures. Employees in this field typically work with laboratory equipment and may require knowledge of molecular biology techniques.

What is the difference between Genefab vs Genetic Technician?

AspectGenefabGenetic Technician
Required CredentialsTypically requires a bachelor's degree in genetics, biology, or related fieldUsually requires an associate's degree or bachelor's in genetics or biology
Work EnvironmentLaboratories, research facilities, biotech companiesLaboratories, hospitals, research institutions
Industry UsageBiotech, pharmaceutical, research organizationsHealthcare, research, diagnostics
Common Search/ComparisonGenefab vs Genetic Technician

Both roles involve working with genetic material, but Genefab often refers to a company or brand name, while Genetic Technician is a specific job title. Genetic Technicians typically have similar educational backgrounds and work environments as Genefab employees in biotech or research settings. The main difference lies in the context: Genefab may be a company, whereas Genetic Technician describes a professional role within the industry.

How to get a job in gene therapy?

To get a job in gene therapy, candidates typically need a relevant degree such as a master's or Ph.D. in genetics, molecular biology, or biomedical sciences. Gaining experience through internships, research projects, or certifications in gene editing tools like CRISPR can improve prospects. Strong laboratory skills, understanding of regulatory requirements, and staying updated on advancements are also important.
What are popular job titles related to Genefab jobs in California? For Genefab jobs in California, the most frequently searched job titles are:
What job categories do people searching Genefab jobs in California look for? The top searched job categories for Genefab jobs in California are:
What cities in California are hiring for Genefab jobs? Cities in California with the most Genefab job openings:
Genefab jobs near you
Infographic showing various Genefab job openings in California as of August 2026, with employment types broken down into 80% Full Time, and 20% Temporary. Highlights an 100% Physical job distribution.

Advanced Therapies CMC Program Manager

GeneFab

Alameda, CA • On-site

$175K - $200K/yr

Full-time

Re-posted 10 days ago

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.
$175,000 - $200,000 a year
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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