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.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
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 computerized 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, change documents, and reports for projects and maintenance activities.
- Review and approve Validation Documentation including but no limited to: Validation Master Plans, User Requirements, Functional Requirements, IQOQPQ, Trace Matrix, Validation Summary Reports and Change Controls.
- Provide quality and compliance oversight for the qualification, and validation, of computerized systems with manufacturing, facility, and laboratory processes.
- Provide quality and compliance oversight for scheduled activities within the manufacturing and testing facility. Including, review and approval of documentation.
- 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
- 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, IT, or Science
- 3-5 years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements
- Prior experience in developing, reviewing, and approving validation documentation for software validation within manufacturing, and laboratory areas.
- 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 support validation activities.
- 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.
- 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.
- 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.