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Program Manager, Contract Research, Development, and Manufacturing Organization

GeneFab · Alameda, CA · Integrated Project Team, coordinating technical functions and sponsor partners

Compensation

$140k – $200k /yr

Employment type

Full-time

Work setting

On-site

Location

Alameda, CA

Schedule

Day shift

Posted

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Job overview

The Program Manager, Contract Research, Development, and Manufacturing Organization (CRDMO) role is onsite in Alameda, CA. Compensation is $140,000–$200,000 per year. The role supports GeneFab, a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. The manager leads cross-functional programs across the product development lifecycle, coordinating technical work, sponsor collaboration, regulatory readiness, resources, budgets, and risks. The role’s shared-accountability approach is intended to align internal teams and sponsors around program outcomes and delivery.

What you'll do

  • Lead workstreams within Integrated Project Teams and co-own program outcomes
  • facilitate team and steering committee meetings
  • drive governance escalations and improve PMO frameworks
  • lead end-to-end program execution from therapeutic design through regulatory submission readiness
  • align synthetic biology, process development, analytical development, MSAT, quality control, and manufacturing
  • coordinate knowledge transfer
  • co-lead CMC regulatory strategy and submission content roadmaps
  • serve as primary sponsor and client contact
  • manage scope, deliverables, budgets, forecasts, invoicing, and risks.

What we're looking for

Skills & competencies
program manager
crdmo
cell and gene therapy
cmc program management
integrated project delivery
biotechnology
regulatory submissions
sponsor partnership
alameda ca
genefab
$140k–$200k/year
Work arrangement
  • Weekend coverage required

Why this role

Bachelor’s degree in life sciences, bioengineering, chemical engineering, or related field required. Requires 5–8+ years of CMC program management experience across the full CMC lifecycle; advanced degree and PMP/IPD/Lean training are preferred or a plus.

About the employer

GeneFab is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.

Additional details

Industry sector
54
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Occupation code
11-9199.00
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