Quality Control Sample Coordinator

We are seeking an innovative, creative, and detail-oriented Quality Control Sample Coordinator to join our team in Bridgewater, New Jersey. This individual will play a critical role in ensuring the seamless handling, tracking, and shipping of analytical samples in support of assay execution for the Quality Control (QC) teams. This position acts as the central point of contact between Manufacturing, Analytical teams (multi-site), and other cross-functional stakeholders in managing sample logistics and documentation. All activities are performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

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.

Responsibilities

• Create and maintain sample schedule, from sample creation through QC testing
• Track sample shipments between internal and external sites
• Receive samples from clients or other Cellares sites and ensure proper logging, handling, & reconciliation
• Maintain visibility into sample storage locations, including LN2 and -80°C freezers
• Manage documentation related to the shipping and receiving of samples
• Document sharing & coordinate ordering cryoports/cryopods with the Warehouse team and coordinate shipment/reshipment logistics for analytical samples
• Be comfortable working with LN2 systems
• Work with QC teams in developing and managing sample batching approaches
• Deliver required samples to the QC team in real time
• Monitor for and address discrepancies (labels not accurate, vial missing, wrong concentration, etc) proactively
• Be available to support unplanned analytical re-executions
• Review the assay execution schedule and monitor turnaround times for data release to ensure alignment with project timelines
• Ensure sample retains are shipped to appropriate long-term storage locations after assay execution
• Assist in general upkeep of the laboratory and maintain a clean work environment
• Perform other duties as assigned
  
  

Requirements

• Bachelor's degree in a science discipline required, or comparable experience
• 2 years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment is preferred
• Prior experience related to LN2 sample handling is preferred
• Prior experience with scheduling/planning tools (e.g Binocs) is preferred
• Knowledge of pharmaceutical cGMP (US and EU) is preferred
• Must have excellent verbal, written, interpersonal, and organizational and communication skills
• Must be able to commute to Bridgewater, New Jersey
• Self-awareness, integrity, authenticity, and a growth mindset
  
  

$90,000 - $210,000 a year

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.