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Job Descrption

We are seeking an innovative and highly motivated GMP Metrology Lead who will contribute significantly to Cellares' growth and our mission to accelerate access to life-saving cell therapies.
The GMP Metrology Lead will be responsible for the metrology program for the facility and equipment for new projects and existing systems for the Cellares IDMO Facilities. This individual will be responsible for the efficient and effective development and management of all aspects of the metrology program, overseeing facilities, utilities, and equipment supporting cell therapy manufacturing. The GMP Metrology Lead ensures facilities and equipment are appropriately calibrated and maintained according to quality standards and good manufacturing practices. The metrology lead provides daily support activities such as documentation, adherence to procedures, equipment scheduling, and calibration metrics reporting. Assure department compliance with applicable internal and external regulatory requirements and procedures.
Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle various challenges as the company grows.

Responsibilities

• Lead the facility and equipment metrology program including owning the asset management of the Bridgewater, NJ IDMO site
• The metrology lead provides daily support activities such as documentation, procedure adherence, equipment scheduling, and calibration metrics reporting
• Assure department compliance with applicable internal and external regulatory requirements and procedures. Support internal and external auditing activities
• Develop calibration protocols, methods, and techniques based on the science of measurement, assuring accuracy and precision
• Strategically build a metrology/process equipment team that includes internal employees and external vendors to ensure Cellares project timelines are delivered
• Ensure that laboratory equipment maintenance and calibration programs are maintained and production operational requirements are met
• Develop and report calibration metrics (KPIs)
• Manager calibration suppliers: approval, consolidation, quality, and purchasing.
• Coordinate scheduling of vendor maintenance/calibration for GMP equipment
• Manage calibration program schedule and preventative maintenance; ensure on-time completion and review of work orders for accuracy and GMP compliance
• Provide technical support to operations and support personnel maintaining equipment operations
• Assist in the development of a monthly schedule for GMP clean room maintenance activities
• Manage work requests/orders, including processing, generation, tracking, and follow-up; ensure work order completion, review, approval, and close-out
• Maintain all equipment data within a CMMS
• Ensure all assets are documented, maintenance plans are developed, assets are scheduled, and work orders are complete
• Develop and implement calibration and equipment maintenance procedures. Author/Review/Approve documents for departmental standard operating procedures (SOPs) and programs
• Author, assess, and execute Change Controls and Impact Assessments for facility and equipment.
• Demonstrate effective program leadership and team collaboration by completing all assigned projects on time and on budget and successfully achieving expectations in compliance with our safety policies and company regulations
• Manage and maintain the metrology program expenses and capital budget
• Participate and lead in developing corporate-wide systems, procedures, and tools that facilitate efficient processes throughout the organization
• Ensure and support the EHS team in complying with all regulations and guidelines for a cell therapy manufacturing facility
• Ownership for, develops, and continually improves metrology programs
• Make critical decisions on equipment/facility issues and emergencies, effectively communicate with management, and escalate issues 
• Create a GMP culture mindset within the metrology/engineering team supporting the cell therapy manufacturing organization

Requirements

• Bachelor's degree in Engineering or related field or equivalent work experience required
• A minimum of 10 years of experience in a regulated industry and 5 years experience in direct equipment program management
• Preferred candidate would have previous experience working for a cell and gene therapy organization
• Maintain accurate working knowledge of governmental/regulatory requirements related to facility/equipment, including FDA, EMEA, and other regulatory standards
• Ability to work independently and in a team environment with the ability to successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively
• Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
• Advanced knowledge of GMP facilities and equipment, including best industry practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment
• An understanding of facility 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 the 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
• Proficient utilizing a computerized maintenance management program

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.

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