We are seeking an innovative and highly motivated Director, Engineering and Facilities, who will contribute significantly to the growth of Cellares and our mission to accelerate access to life-saving cell therapies.
The primary focus of this position, as Director, Engineering and Facilities, is responsible for management, operations, and maintenance of all facilities and supporting systems in compliance with GMP, quality, and EHS standards. This role oversees office space, cGMP cleanroom suites, QC laboratories, warehouse, utility systems (gases, HVAC, lab equipment, etc.), and equipment supporting cell therapy operations. In addition, the Director leads the maintenance and calibration program, cleaning program, and capital expansion projects (CAPEX), including buildouts.
The ideal candidate is an experienced facilities leader with a strong background in cGMP operations within the biotech or pharmaceutical industry. This individual will provide vision and leadership to ensure reliable facility operations, compliance with state and federal regulations, and continuous improvement of processes to support business growth.
This is a multidisciplinary role, and this individual will interface across many parts of the company (with scientists, researchers, and engineers) to develop the best solutions possible. The successful candidate will be driven, motivated, and self-sufficient.
Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.
Responsabilities Develop and implement facilities policies and practices (SOPs)Drive planning activities, including direct space allocations, moves, and facilities construction, modification, and maintenanceManage and coordinate equipment calibrations, preventive maintenance, and monitoring of equipment and utilities in non-GMP and GMP areas (including repair, modification, and installation of equipment)Establish a computerized equipment maintenance and calibration program using a modern eQMS platformManage a building monitoring program, including sourcing, approving, and implementing an electronic building monitoring systemSupport an equipment monitoring system for GMP-related equipmentManages and coordinates the contract cleaning services for the GMP facility and office space areasResponsible for emergency repairs of the facility and equipmentReview and approve equipment and facilities-related contracts and vendor qualificationsManage and lead capital engineering projectsManage and coordinate the facility pest control program for the GMP and non-GMP areas.Oversee Environmental Health and Safety (EHS) activities as they relate to the GMP and non-GMP environments, including sourcing contract personnel for chemical and biological waste disposalCapture, analyze, prioritize, delegate, and communicate immediate, short-term, and long-term maintenance projectsSupport and assist with expertise in electrical, plumbing, welding, HVAC, refrigeration systems, and other equipmentResponds to emergencies as appropriate during off-hours, holidays, and weekendsDevelops and maintains accurate records of maintenance activitiesResponsible for monitoring and ordering compressed gasesOversees and manages third-party service providersManage the direct relationship with landlords and/or property managers to ensure correct building maintenance and compliance with contractual agreementsAuthor Request Proposal (RFP) documents for vendors to bid on qualification work and provide vendor comparisons, and award qualified vendorsDevelop and implement commissioning and qualification proceduresAuthor, review, and approve documents for departmental standard operating procedures (SOPs) and programsGeneration and execution of qualification documents, URS, RA, SAT, FAT, IQ, OQ, PQ, and summary reports to support GxP requirementsDevelop, review, and approve room qualification protocols for static and dynamic classified environmentsAuthor, assess, and execute Change Controls and Impact Assessments for Engineering/Facilities qualification projectsProvide qualification project updates to stakeholders and management personnel, such as phase gate reviews, meeting minutes, status updates, and identification and tracking of project risksDemonstrate effective project leadership and team collaboration by completing all assigned projects on time, on budget, and successfully achieving qualification expectations in compliance with our safety policies and company regulationsManage and maintain the commissioning and qualification expense and capital budgetParticipate and lead in the development of corporate-wide systems, procedures, and tools that facilitate efficient processes throughout the organizationEnsure and support the EHS team in complying with all regulations and guidelines for a cell therapy manufacturing facilityMaintain all commissioning and qualification data within a secure, structured CMMS systemEnsure all assets are documented, maintenance plans are developed, assets are scheduled, and work orders are completedTake ownership of, develop, and/or continually improve commissioning and qualification programsParticipate in external and internal compliance/regulatory auditsMake critical decisions on equipment/facility issues and emergencies, effectively communicate to management, and escalate issues as needed Requirements Bachelor's or Master's degree in Engineering or related field10+ years of direct experience working in a GMP-regulated facility in the pharmaceutical or life sciences arenas is a mustA minimum of 3 years of experience working in a cell therapy or pharmaceutical manufacturing environment, with at least 1 of those years in a director of operations roleHands-on experience with autologous and/or allogeneic cell therapy manufacturing processesDirect experience managing facility office spaceDetailed knowledge of manufacturing technology, industry trends, and requirements associated with the introduction of new equipment/methods into a manufacturing settingDemonstrated success managing CAPEX projects, facility buildouts, and utility systemsComprehensive understanding and extensive practical experience with GMP quality systems and proceduresExcellent technical writing skills with an understanding of good documentation practicesAbility to adapt and evolve quickly in an ever-changing and dynamic environmentSelf-motivated and able to collaborate well cross-functionally with other department managers and personnelShould be passionate about advancing the field of cell therapiesSelf-awareness, integrity, authenticity, and a growth mindsetMust be able to travel up to 20% of the time Additional Information This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
Compensation Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
