Cell Therapy Manufacturing Specialist
4 weeks ago
We are seeking a highly skilled and experienced Quality Control Manager to join our team at Cellares, a company developing and operating integrated technologies for cell therapy manufacturing.
This role will be responsible for ensuring the quality control lab is held to GxP standards and safety standards, creating, reviewing and approving Certificate of Analysis, conducting investigations regarding out of specifications (OOS) results and addressing and managing deviations related to analytical procedures.
The ideal candidate will have a strong background in cell biology, immunology, and molecular biology, as well as a working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211.
Responsibilities will include:
- Schedule and 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 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
- 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
Requirements include:
- 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
- ~ 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
- ~ Equipment IQ/OQ/PQ experience
- ~ Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
Cellares offers a competitive total compensation package, including highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.
Cellares is backed by world-class investors and has raised over $355 million in financing.
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