Manager, Quality Control

Requirements

• BA or B.S. degree in a science discipline required, or comparable experience; M.S. in a scientific discipline is preferred
• Minimum of 7 years experience in a cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
• At least 2 years in a managerial role
• Prior experience related to method development/validation preferred
• Strong background in cell biology, immunology, and molecular biology and associated analytical assays
• Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
• Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, analytical testing, and auditing
• Identifying, authoring, and supporting OOS, DRs, and CAPAs
• Equipment IQ/OQ/PQ experience
• Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
• Excellent interpersonal, verbal, written communication and organization skills
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset

Additional Information

We are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our GMP manufacturing facility located in Bridgewater, NJ. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products. This individual will lead a group of QC analysts performing analytical testing of in-process and final product from cell therapy products. They will interface across different parts of the company to support novel products used in cell and gene therapy. This role will report to the Senior Director of Quality Control. 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. 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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