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Senior Manager, Facilities
Cellares
Administration, Operations
South San Francisco, CA, USA
Posted on Nov 9, 2024
Position Summary
We are seeking an innovative and highly motivated Senior Facilities Manager 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 will be managing Cellares’s SSF facilities including the cGMP clean rooms suites, the QC laboratories, development laboratories, warehouse, utility systems (gasses, HVAC, lab equipment, etc.), and the maintenance and calibration program in addition to maintaining the non-GMP office space and cleaning program. This role provides leadership on the day-to-day functions of the organization, maintains the GMP and non-GMP facility environments, and contributes to management goals and improvements. This role is vital in maintaining the facilities and the subsequent systems in accordance with state and federal laws and agencies. The ideal candidate is seasoned and well versed in GMP and non-GMP facility operations management within the biotech or pharmaceutical industries, and has demonstrated experience as a hands-on leader.
This is a multidisciplinary role that will further interface across many parts of the company to develop the best facilities solutions possible. The successful candidate will be the resident expert in the areas of facilities operation and management. This is a hands-on position.
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.
Responsibilities
- Drive planning activities, including direct space allocations, moves, and facilities construction, modification and maintenance
- Support implementation and drive improvements to facilities policies and practices (SOPs)
- Develop internal facilities team and external service resources to operate and maintain the facility
- Responsible for monitoring and ordering packaged utilities such as compressed gasses and dry ice
- Manage and coordinate equipment calibrations, preventive maintenance, and monitoring of equipment and utilities in non-GMP and GMP areas (including repair, modification, installation, and qualification of equipment)
- Manage the equipment maintenance and calibration program using a modern computerized maintenance management system (CMMS) platform, ensure all planned and unplanned maintenance events are completed in time and documented
- Author engineering change orders (ECO), deviations, or other quality records as needed
- Participate in site audits (internal, client, health authority) as needed
- Develop and maintain accurate records of maintenance activities
- Support review and approve equipment and facilities related contracts and vendor qualifications
- Responsible for establishing alert and alarm response program for all facilities systems and utilities
- Develop and manage environmental monitoring system (EMS) for GMP critical environmental instruments and related GMP equipment
- Manage the building automation system (BAS) including alarm monitoring/responses and modification for continuous improvement
- Manage and coordinate the contract cleaning services for the GMP facility and office space areas
- Manage and coordinate facility pest control program for the GMP and non-GMP areas
- Collaborate with cross functional departments such as Quality and Operations in supporting change controls, quality event investigation, and CAPA execution
- Oversee Environmental Health and Safety (EHS) activities as they relate to the GMP and non-GMP environments including overseeing contract personnel for chemical and biological waste disposal
- Oversee and manage third party facilities service providers
- Capture, analyze, prioritize, delegate, and communicate immediate, short term, and long term maintenance projects
- Provide facility user inputs and field coordination for capital engineering projects
- Develop and manage facilities department annual and long term CapEx and OpEx budget
- Support and assist with expertise in electrical, plumbing, welding, HVAC, refrigeration systems and other equipment
- Responsible for emergency repairs of facility and equipment
- Responds to emergencies as appropriate during off-hours, holidays, and weekends
- Interface with landlords and/or property managers to ensure correct building maintenance and compliance with contractual agreements
Requirements
- Bachelor's degree in Engineering or Facilities related field or equivalent experience
- 10+ years direct experience working in a GMP regulated facility in the pharmaceutical or medical device arenas is a must
- Direct experience leading facilities teams in life sciences or related field
- Comprehensive understanding and extensive practical experience with GMP quality systems and procedures
- Excellent technical writing skills with an understanding of good documentation practices
- Ability to adapt and evolve quickly in an ever changing and dynamic environment
- Self-motivated and able to collaborate well cross-functionally with other department managers and personnel
- Must be passionate about advancing the field of cell therapies
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset