CBM

Full Time Temp

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.

Summary

The Center for Breakthrough Medicines QA Department is seeking a QA Validation Manager 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, change documents, and reports for projects and maintenance activities.

Responsibilities

·      Review and approve Validation Documentation including but no limited to: Validation Master Plans, User Requirements, Functional Requirements, FATs, SATs, IQOQPQ, Trace Matrix, Validation Summary Reports and Change Controls.

·      Provide quality and compliance oversight for the qualification and validation, of manufacturing, facility, and/or laboratory systems.

·      Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility. Including, review and approval of documentation.

·      Work in a collaborative team setting with quality counterparts that includes: Manufacturing Operations, Facilities & Engineering, Information Technology, Testing, and Supply Chain.

·      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

Education & Experience

·      Bachelor of Science degree or higher education in Engineering or Science

·      5-10 years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements. Two (2) years of experience in a leadership capacity.

·      Prior experience in developing, reviewing, and approving validation documentation for equipment, lab systems, utilities, and manufacturing equipment.

·      Experience in writing & reviewing SOPs and protocols for accuracy and compliance

·      Provide guidance and oversight to Specialist level employees.

·      Ability to work closely with multiple disciplines, including: Manufacturing Operations, Facilities & Engineering, Information Technology, Testing, and Supply Chain 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.