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.
· Support execution of New Product Programs and Continuous Improvement projects within the Viral Vector platform at the Center for Breakthrough Medicine.
· Supporting all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make CBM a best in class CDMO facility.
· Candidate must be prepared for an exciting, dynamic, and fast paced CDMO/start up environment.
· Development and revision of Master Batch Records, Work Instructions, Logbooks, Forms and Standard Operating Procedures to support Vector Manufacturing.
· Authoring and creating documents associated with New Products Programs and Continuous Improvement Projects and deliverables for VV.
· Authoring and creating documents associated with the initial stand up of the organization.
· Maintain a culture of Safety, Quality, Delivery, and Operational Performance based on CBM Goals and Vision.
· Maintain Cost Mindfulness and promote Innovation and Team work to meet or exceed Revenue and EBITDA targets.
· Focus on Client Success and Transparency with each program.
· Communicate effectively and timely to address internal and client comments ensuring the document content meets the intention and required details to be successful.
· Participate as a key member of Program Project Teams to complete deliverables On Time in Full.
· Escalate issues that would jeopardize the Program Timeline and milestones.
· Work Cross-functionally on project team and work closely with the shop floor to ensure documents are meaningful.
· Development of Batch Records, SOPs, Training Modules for tech transfer projects and internal vector CAPAs, deviations, and continuous improvement objectives.
· Work closely with process SMEs to execute on Time Technical Transfer of new or optimized programs by ensuring documents are completed and correct.
· Support Quality Audits, Supplier Audits, and Regulatory Inspections.
· Follow Operational Excellence Standards with department
· Manage and track assigned documents through the entire life cycle (i.e. creation, review, revision, approval) using detailed project planning to meet project milestones.
· The ideal candidate is preferred to have a Bachelors Degree in a technical or applicable discipline or equivalent.
· The Ideal candidate is preferred to have 2+ years experience or equivalent.
· Regulatory experience with FDA, EU commercial and Clinical is a plus.
· Knowledge of quality systems or document control systems a plus.
· Strong Cross Functional Communication skills.
· Technical Skills and Experience preferred for the role:
· Technical Transfers
· Project Planning
· Document Creation
· Quality document creation and management
· Problem Solving