GMP Metrology Specialist

We are seeking an innovative and highly motivated GMP Metrology Specialist who will contribute significantly to Cellares' growth and our mission to accelerate access to life-saving cell therapies.

The GMP Metrology Specialist supports the metrology program for Cellares IDMO facilities and equipment, including both new projects and existing systems. This role is responsible for the day-to-day execution of metrology activities, including oversight of vendor calibrations and preventive maintenance for process, laboratory, and facilities equipment.

The GMP Metrology Specialist ensures that all facilities and equipment are properly calibrated and maintained in accordance with applicable quality standards and Good Manufacturing Practices (GMP) to support cell therapy manufacturing operations. Daily responsibilities include documentation management, adherence to established procedures, equipment scheduling, and preparation of calibration metrics and reports for the Metrology Manager.

This position also ensures departmental compliance with all applicable internal policies, procedures, and external regulatory requirements.

Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle various challenges as the company grows.

Responsibilities:
• Support the facility and equipment metrology program, including owning the asset management of the Bridgewater, NJ IDMO site
• 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
• Supporting the development of calibration protocols, methods, and techniques based on the science of measurement, assuring accuracy and precision
• Ensure that laboratory equipment maintenance and calibration programs are maintained, and production operational requirements are met
• Support the Metrology department calibration metrics (KPIs)
• Provide oversight of calibration suppliers: approval, consolidation, quality, and purchasing
• Coordinate scheduling of vendor maintenance/calibration for GMP equipment
• Support the 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
• Supporting the development of calibration and equipment maintenance procedures. Author/Review/Approve documents for departmental standard operating procedures (SOPs) and programs
• Supporting the 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
• Participate 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
• 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:
• Associate’s or technical degree in an engineering-related field, or equivalent relevant work experience, required
• Minimum of 7 years of experience in a regulated industry, including at least 3 years of direct equipment or metrology program management experience
• Experience in cell and gene therapy and/or pharmaceutical manufacturing is strongly preferred
• Working knowledge of applicable governmental and regulatory requirements related to facilities and equipment, including FDA, EMA, and other relevant regulatory standards
• Ability to work independently and collaboratively in a team environment, with proven ability to prioritize and manage multiple tasks while balancing competing priorities
• Demonstrated ability to adapt to shifting priorities and meet critical deadlines in a fast-paced, dynamic, and growing environment
• Ability to read and interpret engineering drawings, schematics, and isometrics
• Excellent verbal and written communication skills
• Strong organizational skills with the ability to multitask effectively and maintain attention to detail
• Demonstrated critical thinking and independent decision-making capabilities.
• Ability to handle confidential information with appropriate discretion
• Strong interpersonal and teamwork skills, with the ability to influence and build effective working relationships across all levels of the organization
• Willingness and flexibility to take on responsibilities outside the normal scope of work as needed.
• Desire to contribute to a rapidly evolving organization with compelling technology and mission
• High level of self-awareness, integrity, authenticity, and a demonstrated growth mindset
• Proficiency in using computerized maintenance management systems (CMMS)

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.

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.