The Manager is responsible for the cGMP compliance of the microbiology laboratory and staff at our ElevateBio Waltham facility. This role is responsible for management and oversight of routine and non-routine microbiological activities. This includes scheduling and execution of the environmental monitoring program, utilities testing program, raw material, in-process, and product release testing. The Manager will also be responsible for method development, method transfer, and method validation. The Manager will oversee data review, data trending and present periodic trending reports to senior management. Here's What You'll Do:
- Implement a compliant risked based environmental and utilities monitoring programs that meets global standards
- Manage laboratory support of production by ensuring the timely release of manufacturing areas, utilities, raw materials, in-process, and finished product test results
- Review, trend and present Microbiological data
- Review and approve microbiology laboratory SOPs, protocols and reports
- Oversee microbiology laboratory and environmental investigations, including deviations, OOS, OOT and CAPAs
- Participate in regulatory inspections and facility audits
- Serve as the technical subject matter expert on microbiological assays/techniques and troubleshoots microbiology related issues
- Support management of contamination control strategy document
- Hire, train and develop microbiology staff
Note: Weekend and evening hours required Requirements:
Why join ElevateBio?
- Bachelor's degree in technical discipline (Microbiology or related field) with a minimum of 7 years of experience in a cGMP Quality Control microbiology lab setting (preferably in aseptic manufacturing site)
- Prior supervisory responsibilities
- Prior hands-on experience with compendial microbiological methods such as endotoxin, bioburden, sterility, environmental and utilities monitoring, TOC/Conductivity, and microbial identification
- Experience with clean room and utilities qualification per ISO 14644, Annex 1, and ISO 8573
- Experience with rapid methodologies (BacT, MCS, Milliflex Rapid Sterility)
- Ability to communicate and work independently with scientific/technical personnel.
- Ability to work in a dynamic start-up environment
- Strong knowledge of FDA regulations pertaining to cGMPs, international regulations, quality system processes, and industry practices.
- Excellent organizational skills.
- Experience in cell and gene therapy manufacturing environment a plus
- Experience performing laboratory investigations and method qualifications
- Competent in use of various computer programs (Excel, PowerPoint, Smart sheets)
ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.
At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists. Our Vision:
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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