Manager, Quality Control
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
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.