Senior Quality Control Analyst, Microbiology

We are seeking an innovative, creative, and detail-oriented Senior Quality Control Analyst, Microbiology to join our team in Bridgewater, New Jersey. This position will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs).  This role supports the day-to-day operations within the Quality Control group via execution of Environmental Monitoring and microbiological testing. All activities are performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures. 

This role will be hands-on resource reporting to the Quality Control Manager, Microbiology.  The level will be determined based upon the candidate’s education, skills, and/or related experience. 

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.

• Responsible for performing microbiological testing of raw materials and cell therapy products in accordance with organization’s policies and SOPs
• Serve as a deputy for the QC Microbiology Manager during absences, ensuring continuity of operations and decision-making, flexibility to handle additional responsibilities and dynamic situations
• Responsible for performing routine and non-routine microbiology testing such as B&F and sterility test, bioburden testing, growth promotion testing of purchased media (iNST & iAST bottles, TSA RODAC and Settle plates, etc.) bacterial endotoxin method development/verification and routine testing, gram stain, microbial readings, investigational testing
• Ability to work effectively within controlled environments under cGMP regulations, responsible for overseeing and maintaining gowning qualification program
• Participate in aseptic process simulation activities (APS)
• Support method qualification and transfer activities and participate in validation of microbiological methods commensurate with experience
• Conduct Environmental Monitoring of controlled environments (ISO 5 production isolators, ISO 8 cleanrooms, CNC) including non-viable and viable air particulate, surface viables in a GMP manufacturing facility
• Participate in EMPQ activities, assist in developing sampling plans and routine EM program for new cGMP cleanrooms and adjacent controlled areas as per ISO and other regulatory requirements
• Conduct utilities monitoring of compressed gas systems including CDA, N2, CO2 (non-viable and viable air particulate) in a GMP manufacturing facility
• Responsible for training of team members for GMP testing; effective communicator and deep technical expertise in key microbiology assays, to be able to share and communicate that knowledge through training of analysts
• As a senior team member responsible for providing technical support and guidance to lab staff, assisting with troubleshooting and experimental design, leading investigational studies
• Responsible for authoring trend reports for EM and utilities, also review reports that are generated and make conclusions as to any action required based on the data
• Document results accurately in laboratory notebooks, LIMS, ELN, and batch records
• Perform timely and accurate peer review of test results/reports, compile and review data to ensure accuracy and regulatory compliance
• Collaborate with cross functional teams to develop and execute process improvement strategies ensuring alignment with organizational goals
• Responsible for development and management of SOPs, forms, and method protocols/reports required to support compliant operation and testing conducted in the microbiology laboratory
• Communicate effectively with management regarding road needs, task completion and issues related to QC Microbiology division
• Investigate and document non-conforming events, OOS and EM excursions
• Provide expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations and change management processes
• Support Quality Systems such as change control, deviation, CAPA, audits, quality metrics, etc.
• Responsible for reviewing all data in compliance with applicable procedures and cGMP requirements as well as data integrity principles
• Interface with contract testing laboratories a technical expert (e.g. microbial identification services)
• Prepare COA/COT for testing performed
• Participate in internal assessments and audits as required, supply quality control data necessary for regulatory submissions
• Support equipment validation, calibration, maintenance, and troubleshooting
• Maintain lab inventory, ensuring proper stock levels of media, reagents and consumables to support uninterrupted operations
• Assist in maintaining a clean and safe laboratory environment, adhering to all safety and compliance requirements
• Perform other duties as assigned

• B.S. degree in a science discipline required, or comparable experience
• 5 years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
• Prior experience with EMPQ, Environmental Monitoring and microbiological assays (endotoxin, sterility)
• Familiarity with rapid microbiology technology such as BAC-T, Nexgen-MCS is highly preferred
• Sterility and endotoxin method qualification and transfer experience is highly preferred
• Good adherence with current Good Manufacturing Practices (cGMP), ISO regulations (ISO 14644), USP chapters, FDA regulations and understanding of 21 CFR, USP, EP and FDA microbiology testing requirements
• Experience in participating in audits and providing audit requests (internal and external including regulatory inspections)
• Deep understanding of contamination control and aseptic processes, Knowledge of cleanroom classifications and requirements (ISO 5-8), ability to work in a cleanroom environment and adhere to gowning protocols
• Must have excellent verbal, written, interpersonal, and organizational and communication skills
• Must be able to commute to Bridgewater, New Jersey
• Excellent verbal, written, organizational, presentation and interpersonal skills
• Self-awareness, integrity, authenticity, and a growth 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.

Salary : $90,000 - $210,000