Quality Control Manager jobs in Somerset, NJ

Position Summary

We are seeking an innovative and highly motivated individual to join us as the Manager, Quality Control Microbiology at our GMP manufacturing facility located in Bridgewater, NJ. You will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products. 

The primary focus of this position will be to develop and support analytical assays and programs including sterility testing and the environmental monitoring program. Additionally, this position will be a major contributor to the validation of microbiological methods, contamination control program, laboratory setup, equipment purchasing and installation/qualification activities. 

This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world. This role will be a hands-on resource reporting to the Director of Quality Control & Bioanalytics.

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. 

• Performing, managing, and enhancing the safety testing of final drug products, including but not limited to sterility, endotoxins, mycoplasma, in accordance with compendial methods
• Establish, validate, and sustain the environmental monitoring program
• Support EMPQ of the control cleanroom activities
• Manage the validation of rapid release microbiological methods in accordance with USP <1223>, used in QC as well as the transfer and validation of methods to contract testing laboratories
• Collaborate with QC Analytical management in establishing product specifications
• Subject matter expert on investigations of microbiological methods and environmental monitoring
• Subject matter expert on Contamination Control Program
• Assemble and report quarterly, annual, and customized trend reports for environmental monitoring, personnel monitoring, excursions, and out of trend data in support of continuous improvement
• Assemble and report contract laboratory testing data 
• Complete routine record and test data review
• Develop, revise, and review SOPs, qualification/validation protocols and reports
• Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to microbiology procedures
• Establish user requirements for purchase of new Cellares GMP equipment
• Behaves as a working backup QC analyst for testing activities as needed
• Assist in the preparation of dossiers and data packages in support of Cellares products for regulatory agencies
• Manage and grow a phase appropriate team of Quality Control Microbiology personnel, including training QC analysts to perform laboratory procedures and assays
• Serve as Quality Control representative during cross functional project meetings
• Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System
• Other duties as assigned

• Bachelor's degree in Biology, Microbiology, or other laboratory-based life science; or equivalent combination of education and experience.
• 7 years experience in a GMP environment with knowledge of cGMP regulations and a background in microbiology
• 2 years experience leading and developing a team, preferably within a quality environment
• Strong technical knowledge in various microbiological techniques including rapid release methods, environment qualifications, and cellular therapy based products
• Experience in the application of microbiological techniques such as air monitoring, surface monitoring, and genus and species identifications
• Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211, and EU Annex 1, relevant USP/EP methods, and other global regulatory microbiological methods, as applicable
• Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, microbiological 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, and written communication skills
• Comfortable in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset

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.