Position Summary
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 South San Francisco, CA. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.
This is a multidisciplinary role & this individual will further interface across many parts of the company to support novel products used in the cell and gene therapy world. This role will be a hands-on resource reporting to the 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, raw materials, 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
- Collaborate with QC Microbiology management in establishing specifications and justification of specifications
- 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
- Behave as a working backup QC analyst for testing activities as needed
- 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
- Bachelor's degree in a science discipline required, or comparable experience. Master's degree in a scientific discipline is preferred
- 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
- Strong background in cell biology, immunology, and molecular biology
- 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
- Must be able to commute to South San Francisco
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.
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.
