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 direct responsibility for managing day-to-day manufacturing activities, building and developing a high-performing operations team, and ensuring the delivery of safe, high-quality cell and gene therapy products in support of client clinical programs. The ideal candidate brings deep hands-on experience in cGMP biologics or advanced therapy manufacturing, a strong quality mindset, and a proven ability to lead teams in a fast-paced, multi-product environment.
The Sr. Manager/Manager, Manufacturing will serve as a key operational leader at GeneFab, partnering closely with MSAT, Quality Assurance, Quality Control, Supply Chain, Facilities and Process Development to ensure manufacturing readiness, GMP compliance, and continuous improvement across all client programs. 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.
### Key Responsibilities:
The Sr. 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. Key responsibilities include:
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; hire, onboard, mentor, and conduct performance reviews for manufacturing specialists, senior associates, and supervisors.
Champion a culture of quality, patient safety, and operational excellence across all manufacturing activities, ensuring team members always understand and uphold cGMP standards.
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; serve as manufacturing owner for investigations and provide thorough, technically sound root cause analyses.
Review and approve GMP-controlled documents including standard operating procedures, master batch records, material specifications, training materials, and validation protocols and reports.
Develop and maintain a comprehensive training program for cGMP operations and manufacturing systems, ensuring all staff achieve and sustain the competency level required for multi-product clinical manufacturing.
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.
Develop, track, and report departmental KPIs; present operational performance updates and contribute to the development of annual department goals and budgets.
Support capacity planning for clinical and commercial manufacturing campaigns; proactively identify and escalate resourcing or scheduling risks that could impact client program delivery.
Build and maintain effective cross-functional partnerships with Quality, Supply Chain, MSAT, EHS, Facilities and Engineering, and client teams to ensure alignment and seamless execution across all operational activities.
Support regulatory inspection readiness activities including internal audits, mock inspections, and preparation of manufacturing areas and documentation for FDA, EMA, or other agency inspections.
### Supervisory Responsibilities:
Hire, mentor, and develop exceptional manufacturing talent at all levels, from entry-level associates to senior supervisors.
Conduct regular performance reviews and identify opportunities for career growth, skills development, and advancement.
Foster a culture of collaboration, cross-functional inclusion, execution excellence, and effective communication to build a high-performing manufacturing team.
Provide clear direction, coaching, and accountability to direct reports; resolve team conflicts and performance issues in a timely and constructive manner.
### Qualifications:
Bachelor’s degree in a relevant science or engineering discipline required; advanced degree (M.S. or Ph.D.) preferred.
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.
Minimum of 3 years of experience in a supervisory or management role with direct people leadership responsibility.
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.
Strong technical writing capability with demonstrated experience authoring, reviewing, approving, and training staff on SOPs, batch records, change controls, deviations, and CAPAs.
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.
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.
Proficient in MS Office applications; familiarity with electronic batch record (EBR), manufacturing execution system (MES), and quality management system (QMS) platforms preferred.
### Compensation:
Compensation range for Manager: 140-160K
Compensation range for Sr. Manager: 160-180K
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.
