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 Commissioning Qualification Validation (CQV) Specialist will be responsible for providing commissioning, qualification and validation support with regard to site equipment, processes, and/or systems. The successful candidate will be able to validate industrial processes in order to maintain compliance and meet project deadlines. In addition, he/she will handle day-to-day activities including execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell and gene therapy production through safe and compliant manufacturing and testing operations according to cGMP requirements. This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program, and to enable robust production, testing and release of product to patients.
• Participate in providing a planned, documented, and managed approach to the commissioning, qualification testing (post-construction turnover) of validated systems / equipment to the client including any associated maintenance activities.
• Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Supports and/or owns technical and quality investigations, CAPAs and corrections to supporting documentation.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Assist in developing and maintaining a Validation Master Plan (VMP).
• Assist Project Management in determining the appropriate level of validation required using risk-based strategies while ensuring compliance with quality guidelines.
• Conduct monthly and quarterly interviews and maintain close client relationship with plant manager.
• Participate in the development and management of the commissioning and qualification budget.
• Participate in subcontractor plans for commissioning and qualification activities and define deliverables, roles, and responsibilities.
• Assist in developing and maintaining a Commissioning and Qualification Master Plan (CQMP), control all costs associated with commissioning and qualification labor and equipment; and integrate activities and deliverables with ongoing operations, construction management (if present), and commissioning and qualification with multiple parties.
• Participate in any Client project risk management reviews and follow up for mitigation planning and execution.
• Understand existing system boundaries and establish any new system boundaries, scope of work, and commissioning execution plans.
• Establish project specific written commissioning and qualification procedures for new systems and continue re-validation efforts on existing systems.
• Develop written test procedures as well as coordinate, witness, and document startup and functional tests.
• Manage the work to the terms of the contract by eliminating leakage and optimizing returns.
• Manage risk as assigned by the joint Risk Assessment team for systems, project management and or site management by reviewing risk on a regular basis and identifies significant business risk for the project(s).
• Communicate commissioning roles and scope for members of project teams.
• Fulfill contract requirement by ensuring that the duties and responsibilities of the project contract are clearly defined, documented and followed in house as well as CQV subcontractors.
• Align and incorporate new team members through coaching and/or other orientation practices.
• Enhance skills, performance, and development of all employees by sponsoring and promoting training programs so that adherence to procedures and specifications is ensured and work of the highest quality prevails.
• Continually improve personal technical, commercial, and organizational knowledge and skills.
• Typically manage personnel and provide an environment for the development and professional advancement of staff members, including on-the-job and formal training and development opportunities, and timely performance feedback.
Education & Experience
• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum 5 years’ relevant work experience required in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
• Proven work experience in validation required or Current Good Manufacturing Practices (cGMP) or global equivalent related work experience, including at least three (3) years of project management experience.
• Candidate coming from Pharmaceutical Manufacturing with experience with Capital Projects a plus.
• Ability to communicate effectively with management, coworkers, clients, client operations, vendors, contractors, and other stakeholders.
• Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines.