GeneFab

GeneFab

Sr. Manager/Manager, Manufacturing

Alameda, CA · Senior

Sponsorship not specified$140k-$180kDetected 50 days ago
Supply ChainPerformance ManagementGMPFDA RegulatoryCRISPRLeadershipCommunicationCollaborationMentoringWritingMicrosoft Office

About the role

  • GeneFab is seeking an experienced and highly motivated Sr.
  • This individual will be expected to operate with strong ownership and accountability, driving both team performance and operational excellence while maintaining the highest standards of patient safety and product quality.
  • This is a hands-on operational role requiring significant on-the-floor presence and direct Gemba of manufacturing areas during processing runs.

Responsibilities

  • Lead and manage daily cGMP manufacturing operations across cell and gene therapy programs, ensuring all activities are executed in compliance with approved batch records, SOPs, and applicable regulatory requirements.
  • Build, develop, and retain a high-performing manufacturing team
  • Partner with MSAT to plan and execute Engineering Runs and Technology Transfer Runs for new client programs introduced to the site, supporting smooth transitions from process development to GMP manufacturing.
  • Collaborate with Quality Assurance to ensure on-time closure of deviations, CAPAs, and change controls
  • Review and approve GMP-controlled documents including standard operating procedures, master batch records, material specifications, training materials, and validation protocols and reports.
  • Manage manufacturing scheduling, ensuring people, facility, equipment, materials, and documentation are aligned and available to support program timelines and site capacity requirements.
  • Oversee and provide direct on-the-floor operational support during all manufacturing runs and processing activities
  • maintain regular Gemba walks through manufacturing suites and support areas to observe operations firsthand, identify improvement opportunities, and ensure compliance with procedures and cGMP practices.
  • Drive continuous improvement initiatives aimed at increasing right-first-time performance, reducing operational cycle times, and improving overall manufacturing efficiency.
  • Manager/Manager, Manufacturing is expected to maintain a strong operational presence in the manufacturing suites and support areas, actively observing and engaging in daily GMP operations.

Requirements

  • Minimum of 3 years of experience in a supervisory or management role with direct people leadership responsibility.
  • Thorough knowledge of cGMP regulations and regulatory guidelines including 21 CFR Parts 210/211/600/610 and EU GMP, with a demonstrated track record of maintaining compliance in a regulated manufacturing environment.
  • Minimum of 6 years of relevant work experience within a pharmaceutical, biotechnology, or similarly regulated industry, including at least 5 years of direct hands-on experience in cGMP biologics or cell and gene therapy manufacturing.
  • Strong technical writing capability with demonstrated experience authoring, reviewing, approving, and training staff on SOPs, batch records, change controls, deviations, and CAPAs.
  • Proven leadership ability to make sound decisions under pressure, manage competing priorities, and drive accountability across a manufacturing team in a dynamic, multi-program environment.
  • Strong interpersonal and communication skills with the ability to build effective relationships across functions and engage and influence team members in a matrixed organization.

Nice to have

  • Bachelor's degree in a relevant science or engineering discipline required
  • advanced degree (M.S. or Ph.D.) preferred.
  • Experience in cell and gene therapy manufacturing (autologous or allogeneic cell therapy, lentiviral or AAV viral vector production) is strongly preferred
  • CDMO experience is a significant plus.
  • Proficient in MS Office applications
  • familiarity with electronic batch record (EBR), manufacturing execution system (MES), and quality management system (QMS) platforms preferred.

Compensation

  • About GeneFab GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies.
  • GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production.
  • 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.
  • 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.
  • Develop, track, and report departmental KPIs; present operational performance updates and contribute to the development of annual department goals and budgets.

Benefits

  • 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.

Equal opportunity

  • We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
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This listing is sourced directly from GeneFab's careers page and normalized into a canonical job model.