Director of Operations, Viral Vector
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Director of Operations, Viral Vector

King of Prussia, PA

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.

Summary

Center for Breakthrough Medicines is seeking a Director of Operations with proven technical skills to lead a client-oriented team and focus on delivering operational excellence within the organization and industry. The Director of Operations, Viral Vector Manufacturing will provide tactical and strategic oversight of the Viral Vector Manufacturing Operations at CBM, a top Advanced Therapies CDMO. The position’s initial scope will involve development, stand-up, and implementation of the GMP Manufacturing of a multi-product, multi-client manufacturing facility. The role will manage the viral vector manufacturing processes including oversight of the planning, on-time execution, and delivery of quality product as well as being responsible for the development of the manufacturing team and continuous improvement of the manufacturing processes. As part of routine operations, the Director of Operations, Viral Vector will work cross-functionally with other teams within the organization to support site operations. This role presents an exciting opportunity for a highly motivated, results driven, problem solving, and innovative individual to make a significant impact in the rapidly growing field of Advanced Therapies. 

Responsibilities

  • Provide technical leadership for the overall manufacturing operations for viral vector products and advanced therapies
  • Oversee development and implementation of processes, equipment, procedures, operating mechanisms, hiring, training, and qualification for the asset.
  • Build a highly efficient, autonomous manufacturing execution team that targets Right-First-Time success while following GMP, Quality, Regulatory, and Safety Standards
  • Build, maintain, and motivate a multi technology operations team
  • Assist the Team in defining/refining strategic purpose of the manufacturing facility they are overseeing
  • Represent the organizational unit as the prime internal and external contact for site manufacturing operations, conducting interactions with external parties including clients, auditors, and regulatory agencies
  • Lead a cross-functional team and interact heavily with internal stakeholders including Program Leadership, Quality, Finance, Engineering, and Testing
  • Continuously drive operational efficiencies with adherence to schedule, lower conversion cost and increased productivity
  • Establish priorities and assure adequate resources to execute diverse client programs.
  • Share responsibility for short- and long-term resources and facility planning, and perform managerial duties as required, e.g., budgets, personnel performance appraisals, etc.
  • Monitor and report progress of projects within agreed upon timelines, ensuring client and Company objectives are met
  • Develop and manage the budget requirements for each fiscal year and organize the purchase of appropriate capital items as required for projects
  • Report manufacturing and quality performance on a regular basis using various site metrics
  • Direct and monitor department managers to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures
  • Support CBM Culture of “Be Committed, Ignite Innovation, Respect All, Embrace Customers, Empower Small, and always be All In”

Reports to: Vice President, Viral Vector Manufacturing

Compensation: TBD

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