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
Top Skills
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.
The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.
Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
