Sr. Manager/Manager, Manufacturing

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 requirementsBuild, develop, and retain a high-performing manufacturing team; hire, onboard, mentor, and conduct performance reviews for manufacturing specialists, senior associates, and supervisorsChampion a culture of quality, patient safety, and operational excellence across all manufacturing activities, ensuring team members always understand and uphold cGMP standardsPartner 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 manufacturingCollaborate 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 analysesReview and approve GMP-controlled documents including standard operating procedures, master batch records, material specifications, training materials, and validation protocols and reportsDevelop 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 manufacturingManage manufacturing scheduling, ensuring people, facility, equipment, materials, and documentation are aligned and available to support program timelines and site capacity requirementsOversee 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 practicesDrive continuous improvement initiatives aimed at increasing right-first-time performance, reducing operational cycle times, and improving overall manufacturing efficiencyDevelop, track, and report departmental KPIs; present operational performance updates and contribute to the development of annual department goals and budgetsSupport capacity planning for clinical and commercial manufacturing campaigns; proactively identify and escalate resourcing or scheduling risks that could impact client program deliveryBuild 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 activitiesSupport regulatory inspection readiness activities including internal audits, mock inspections, and preparation of manufacturing areas and documentation for FDA, EMA, or other agency inspectionsSupervisory Responsibilities:Hire, mentor, and develop exceptional manufacturing talent at all levels, from entry-level associates to senior supervisorsConduct regular performance reviews and identify opportunities for career growth, skills development, and advancementFoster a culture of collaboration, cross-functional inclusion, execution excellence, and effective communication to build a high-performing manufacturing teamProvide clear direction, coaching, and accountability to direct reports; resolve team conflicts and performance issues in a timely and constructive mannerQualifications:Bachelor’s degree in a relevant science or engineering discipline required; advanced degree (M.S. or Ph.D.) preferredMinimum 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 manufacturingMinimum of 3 years of experience in a supervisory or management role with direct people leadership responsibilityExperience 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 plusStrong technical writing capability with demonstrated experience authoring, reviewing, approving, and training staff on SOPs, batch records, change controls, deviations, and CAPAsThorough 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 environmentProven leadership ability to make sound decisions under pressure, manage competing priorities, and drive accountability across a manufacturing team in a dynamic, multi-program environmentStrong interpersonal and communication skills with the ability to build effective relationships across functions and engage and influence team members in a matrixed organizationProficient in MS Office applications; familiarity with electronic batch record (EBR), manufacturing execution system (MES), and quality management system (QMS) platforms preferredCompensation:Compensation range for Manager: 140-160KCompensation range for Sr. Manager: 160-180KAbout GeneFabGeneFab 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. 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.