GMP Metrology Specialist jobs in United States
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Cellares · 18 hours ago

GMP Metrology Specialist

Cellares is an Integrated Development and Manufacturing Organization focused on accelerating access to life-saving cell therapies. The GMP Metrology Specialist will support the metrology program for Cellares' facilities and equipment, ensuring compliance with quality standards and overseeing calibration and maintenance activities.

BiotechnologyLife ScienceManufacturingMedicalTherapeutics
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Growth Opportunities
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H1B Sponsor Likelynote

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

Qualification

Metrology program managementGMP complianceRegulatory knowledgeCellGene therapyComputerized maintenance management systemsTechnical degreeDocumentation managementTeam collaborationCommunication skillsOrganizational skillsCritical thinkingInterpersonal skills

Required

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
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)

Preferred

Experience in cell and gene therapy and/or pharmaceutical manufacturing is strongly preferred

Benefits

Highly subsidized Medical, Dental, and Vision Plans
401(k) Matching
Onsite lunches
Stock options

Company

Cellares

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Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.

H1B Sponsorship

Cellares has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (2)
2022 (1)
2020 (1)

Funding

Current Stage
Growth Stage
Total Funding
$355M
Key Investors
Koch Disruptive TechnologiesEclipse Ventures
2023-08-23Series C· $255M
2021-05-05Series B· $82M
2020-10-29Series A· $18M

Leadership Team

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Fabian Gerlinghaus
Co-Founder & CEO
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Omar Kurdi
Co-Founder and President
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Company data provided by crunchbase