GMP Facilities Lead
Bridgewater, NJ, USA
Posted on Wednesday, February 7, 2024
We are seeking an innovative and highly motivated GMP Facility Lead who will contribute significantly to the growth of Cellares and our mission to accelerate access to life-saving cell therapies.
The GMP Facilities Lead will maintain all building operations for the Cellares IDMO Facility at the Bridgewater, NJ site. This individual will be responsible for the efficient and effective operation of the IDMO Facility and Equipment supporting cell therapy operations. Additionally, the GMP Facilities Lead is responsible for maintaining the facility by quality standards, Good Manufacturing Practices, and within budget guidelines. The GMP Facility Lead oversees ongoing maintenance and operation of the facility, equipment, utilities, and process gasses.
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.
- Support the facility construction and qualification of facility and equipment of the Bridgewater, NJ IDMO site
- Manage vendor services to support facility operations: Building and Equipment services, Life and Safety Equipment / Systems, Pest Control, Landscaping, Cleaning Services, etc.
- Strategically build a facility team that includes internal employees and external vendors to ensure the facility and grounds are maintained to the highest standards
- Develop and implement processes and procedures for managing facility equipment and utilities
- Manage and maintain the facilities expense budget
- Engage in projects to provide facility construction compliance, design, installation, and operation to meet cGMP requirements
- Ensure and support the EHS team in complying with all regulations and guidelines for a cell therapy manufacturing facility
- Maintain all equipment data within a CMMS. Ensure all assets are documented, maintenance plans are developed, assets are scheduled, and work orders are completed
- Take ownership for, develops and/or continually improves maintenance programs (PM, Work Order System, etc.)
- Provide technical leadership and professional support for the facility and maintenance operations team
- Participate in external and internal compliance / regulatory audits
- Make critical decisions on Plant facility issues and emergencies, effectively communicates to management, and escalates issues as needed
- Create a culture within Facilities for proper maintenance, training, documentation, and teamwork
- Bachelor's degree in Engineering or related field or equivalent work experience required
- Maintains accurate working knowledge of governmental/regulatory requirements as related to equipment, including EPA, OSHA, and the FDA. Monitors and ensures company compliance with regulatory standards
- Advanced knowledge of facility operations including best industry practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment
- Experience in mechanical, electronic, and automation systems in a manufacturing environment. Building Automation Systems and Equipment/Environmental systems knowledge is required
- An understanding of maintenance techniques and construction practices is required. Must be able to read drawings, schematics, and isometrics
- Excellent verbal and written communication skills
- Strong organization skills, as well as the ability to multitask
- Ability to think critically and make decisions on your own
- Ability to hold confidential information at appropriate discretion
- Strong attention to detail
- Must be able to manage shifting priorities to meet critical deadlines in a fast-paced, dynamic, growing environment while providing clear direction to team members
- Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
- Desire to be part of a rapidly evolving organization with a compelling technology and mission
- Ability to pivot as needed and take on duties outside the normal scope of work
- Self-awareness, integrity, authenticity, and a growth mindset are a must
- Must be proficient utilizing a computerized maintenance management program
- Cell/Gene Therapy experience preferred
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.