Manager, Quality Control Microbiology
San Francisco, CA, USA
Posted on Friday, May 19, 2023
We are seeking an innovative and highly motivated individual to join as the Manager, Quality Control Microbiology at our facility located in South San Francisco, CA.
The primary focus of this position will be to develop and support analytical assays and programs including sterility testing and the environmental monitoring program. Additionally, this position will be a major contributor to the validation of microbiological methods, contamination control program, laboratory setup, equipment purchasing and installation/qualification activities.
This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy 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.
- Performing, managing, and enhancing the safety testing of final drug products, including but not limited to sterility, endotoxins, mycoplasma, in accordance with compendial methods
- Establish, validate, and sustain the environmental monitoring program
- Support EMPQ of the control cleanroom activities
- Manage the validation of rapid release microbiological methods in accordance with USP <1223>, used in QC as well as the transfer and validation of methods to contract testing laboratories
- Collaborate with QC Analytical management in establishing product specifications
- SME on investigations of microbiological methods and environmental monitoring
- SME on Contamination Control Program
- Metrics: Assemble and report quarterly, annual, and customized trend reports for environmental monitoring, personnel monitoring, excursions, and out of trend data in support of continuous improvement
- Metrics: Assemble and report contract laboratory testing data
- Complete routine record and test data review
- Develop, revise, and review SOPs, qualification/validation protocols and reports
- Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to microbiology procedures
- Establish user requirements for purchase of new Cellares GMP equipment
- Behaves as a working backup QC analyst for testing activities as needed
- Assist in the preparation of dossiers and data packages in support of Cellares products for regulatory agencies
- Manage and grow a phase appropriate team of Quality Control Microbiology personnel, including training QC analysts to perform laboratory procedures and assays
- Serves as Quality Control representative during cross functional project meetings
- Established and promotes an environment that supports the Quality Policy, Data Integrity and Quality System
- Other duties as assigned
- B.S. degree in Biology, Microbiology, or other laboratory-based life science; or equivalent combination of education and experience
- Minimum of 7 years’ experience in a GMP environment with knowledge of cGMP regulations and a background in microbiology and a minimum of 2 years’ experience leading and developing a team, preferably within a quality environment
- Strong technical knowledge in various microbiological techniques including rapid release methods, environment qualifications, and cellular therapy based products
- Experience in the application of microbiological techniques such as air monitoring, surface monitoring, and genus and species identifications
- Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211, and EU Annex 1, relevant USP/EP methods, and other global regulatory microbiological methods, as applicable
- Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, microbiological 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, and written communication skills
- Comfortable in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
This is Cellares
Cellares is creating the future of cell therapy manufacturing. The company is developing an innovative cell therapy manufacturing solution that is robust, cost-effective and scalable so that cell therapies are more affordable and widely available to patients in need. Our multidisciplinary team comes together from diverse backgrounds with a shared passion for accelerating access to life-saving cell therapies. We value integrity, curiosity, the courage to grow and embrace change. At Cellares, you will collaborate with a world class team of engineers, scientists, and business leaders who are as excited about improving the world as you are.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
See more open positions at Cellares
Something looks off?