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
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.
