We are seeking an innovative, creative, and detail-oriented Senior Quality Control Analyst 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 analytical testing. This includes but is not limited to in-process testing, lot release testing, stability testing, and raw material testing. All activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.
This role will be a hands-on resource reporting to the Quality Control Manager. 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.
- Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples
- Work with cell therapy products and associated assays (dPCR, qPCR, cell-based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.)
- Perform timely and accurate peer review of analytical test results/reports
- Prepare COA/COT for testing performed
- Identify discrepancies, initiate and investigate OOS/OOT results for phase 1 and phase 2
- Initiate and investigate deviations related to quality control
- Compile and review data to ensure accuracy and regulatory compliance
- Support development for specifications and justification of specifications
- Participate in validation and technical transfer of analytical methods commensurate with experience
- Write and revise test methods
- Maintain required training and training records and provide training to qualify other associates
- Participate in internal assessments and audits as required
- Support equipment validation, calibration, maintenance, and troubleshooting
- Write method validation protocol/reports and other documentation such as test reports
- Write stability protocol and stability reports
- Write and revise Quality Control Standard Operating Procedures
- Supply Quality Control data necessary for regulatory submissions
- Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc
- 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
- 5+ 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 method development/validation
- Prior experience with immune cell phenotyping by multicolor flow cytometry, dPCR, qPCR, cell-based potency and other cell therapy related assays 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
- 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.
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.
