We are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our GMP manufacturing facility located in Bridgewater, NJ. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.
This individual will lead a group of QC analysts performing analytical testing of in-process and final product from cell therapy products. They will interface across different parts of the company to support novel products used in cell and gene therapy. This role will report to the Senior Director of Quality Control.
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
- Schedule/Manage routine and non-routine analysis of in-process, finished goods, or stability samples
- Ensure the quality control lab is held to GxP standards and safety standards
- Create/Review and approve Certificate of Analysis
- Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to analytical procedures
- Review and approve data to ensure accuracy and regulatory compliance
- Create/Review and approve new and revision of analytical test methods
- Create/Review and approve method validation protocols/reports and other documentation such as analytical reports
- Create/Review and approve stability protocols and reports
- Create/Review and approve quality control operation procedures
- Manage the validation of analytical methods used in QC as well as the transfer and validation of methods to contract testing laboratories
- Manage training of other analysts to perform laboratory procedures and assays
- Participate in internal assessments and audits as required
- Manage stability program
- Serve as Quality Control representative during cross-functional/project meetings
- Serve as subject matter expert between Quality Control and other departments, vendors, or contractors
- Support Quality Systems such as Change Control, Deviation, CAPA, Audits, Quality Metrics
- Manage and grow a phase appropriate team of Quality Control personnel
- Establish user requirements for purchase of new Cellares GMP lab equipment
- Manage equipment validation, calibration, maintenance, and troubleshooting
- Assemble and report contract laboratory testing data
- Assist in the preparation of dossiers and data packages in support of Cellares products for regulatory agencies
- Other duties as assigned
Requirements
- BA or B.S. degree in a science discipline required, or comparable experience; M.S. in a scientific discipline is preferred
- Minimum of 7 years experience in a cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
- At least 2 years in a managerial role
- Prior experience related to method development/validation preferred
- Strong background in cell biology, immunology, and molecular biology and associated analytical assays
- Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
- Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, analytical testing, and auditing
- Identifying, authoring, and supporting OOS, DRs, and CAPAs
- Equipment IQ/OQ/PQ experience
- Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
- Excellent interpersonal, verbal, written communication and organization skills
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
Skills Required
- BA or BS in a science discipline (or comparable experience)
- M.S. in a scientific discipline
- Minimum 7 years experience in cGMP/cGxP operational support in pharma or biotech
- At least 2 years in a managerial role
- Experience with method development and validation
- Strong background in cell biology, immunology, and molecular biology and associated analytical assays
- Working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
- Experience with controlled documentation, data systems, SOPs, analytical testing, and auditing
- Experience identifying, authoring, and supporting OOS, DRs, and CAPAs
- Equipment IQ/OQ/PQ experience
- Proficiency in MS Office (Word, Excel, Outlook, PowerPoint)
- Excellent interpersonal, verbal, written communication and organizational skills
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
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.
