Senior Director of Plasmid Manufacturing
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Senior Director of Plasmid Manufacturing

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

The Senior Director of Plasmid Manufacturing will direct the upstream and downstream operations of plasmid manufacturing in The Discovery Labs Center for Breakthrough Medicine’s state-of-the-art commercial biopharmaceutical manufacturing facility in King of Prussia, PA. He/She is accountable for building, maintaining, and continuously improving a highly effective plasmid production workforce, driving activity to achieve the desired departmental, site, and company outcomes, and ensuring the highest standards of workplace safety and product quality are adhered to. They will provide direct leadership for the Plasmid Manufacturing team and are a key-value stream leader for customer projects providing both technical and operational leadership and expertise. The Sr. Director of Plasmid Manufacturing will provide the leadership, management, and vision necessary to ensure that the company has the proper controls, KPI, people, and systems in place within the manufacturing function.

Responsibilities

  • Establish programs, practices, and processes to drive a high-performance culture and engaged workforce across Safety, Quality, Delivery, and Cost
  • Direct all day-to-day plasmid manufacturing operating including but not limited to manufacturing, manufacturing support, & manufacturing compliance to ensure delivery of departmental commitments to achieve company objectives
  • Work with internal stakeholders in manufacturing, process development, process sciences, project management, etc. to facilitate successful project and customer management
  • Develops and implements Key Performance Indicators to track and lead successful, the timely achievement of goals, objectives, and projects
  • Evaluate the functional strengths and developmental areas in the Plasmid manufacturing team and focus on continuous improvement

Qualifications

  • Advanced degree in Biology, Biochemistry, Chemistry, Engineering or related field
  • 5-10 years hands-on experience in biotechnology/plasmid manufacturing practices, guidelines, management practices, cell and gene therapies knowledge, and production and planning operations.
  • 5-10 years in a Manufacturing/Operations Leadership role, leadership and management experience in a cGMP environment is required

Compensation: TBD

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