Quality Control Manager
3 days ago
We are seeking a highly skilled and experienced professional to join our team as the Manager of Quality Control at Cellares, a leading Integrated Development and Manufacturing Organization (IDMO) in the cell therapy industry.
Job Summary:The Manager of Quality Control will be responsible for ensuring the quality of our cellular therapy products and processes, while also leading a team of quality control personnel. This is a hands-on role that requires a strong background in quality systems, regulatory requirements, and analytical testing.
Key Responsibilities:- 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 investigations regarding out-of-specification (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 revised 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
- Bachelor's degree in a science discipline required, or comparable experience
- 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
Cellares offers a competitive total compensation package, including a base salary range of $90,000 - $210,000 per year, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.
All displayed pay ranges are approximate, negotiable, and location-dependent.
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