The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
The Center for Breakthrough Medicines QA Department is seeking a QA Validation Specialist responsible for providing quality oversight of the validation and qualification activities for manufacturing process, facility, equipment, and systems within a Cell and Gene Therapy manufacturing facility supporting both clinical and commercial programs in a sterile GMP environment. This role will be responsible for reviewing and approving validation/qualification protocols/reports, standard operating procedures, investigations, work orders, change documents, reports for projects and maintenance activities.
- Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Operations Technical Support, Testing, Supply Chain, and Planning
- Provide quality and compliance oversight for the qualification, and validation, of manufacturing, laboratory and testing processes. Including, review and approval of master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
- Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility. Including, review and approval of documentation supporting Plant and Laboratory Maintenance, whose function is to perform planned (Preventative maintenance) and unplanned (work orders and change controls) maintenance for equipment and instruments
- Review and approve Risk Assessments, Change Controls, SOPs, FMEA, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
- Ability to manage multiple and complex projects, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks
- Judgment and problem-solving - able to define decision criteria and determine the most appropriate course of action.
- Planning and organizational skills - able to establish objectives and schedule tasks/resources efficiently.
- Communication skills - strong written communication skills to provide concise and clear documentation
- Partner with a team setting to support continuous improvement initiatives. Support technical and quality investigations to resolve issues
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
- Require minimal direction to complete tasks, knows how to obtain resources and information from established internal contacts; consult with manager for decisions outside established processes
- Bachelor of Science degree or higher education in Engineering or Science
- 3-5 years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements
- Experience in technical writing for cGMP documents
- Prior experience in developing equipment validation, process validation, packaging qualification and cleaning validation
- Must be highly skilled in cleaning validation including protocol and cleaning validation study generation, sample collection and testing
- Experience in writing & reviewing SOPs and protocols for accuracy and compliance
- Ability to work closely with multiple disciplines, including Manufacturing, Maintenance, Facilities, Quality Control, Laboratory and Quality Assurance to execute validation protocols
- Ability to apply comprehensive knowledge of pharmaceutical cGMPs and quality system controls, procedures and records to ensure ongoing quality compliance
- Ability to perform all requirements independently with limited managerial oversight
- Excellent organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efficiencies in a dynamic customer-focused environment
- Superior attention to detail to ensure accuracy of work product
- Superior critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues
- Advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge