Associate Director, Cell Therapy Manufacturing
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Associate Director, Cell Therapy 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

Center for Breakthrough Medicines is seeking an experienced Manufacturing leader to bring our current Good Manufacturing Practices (cGMP) Cell Therapy manufacturing facility online, build the manufacturing team and manage and supervise the production activities. The Associate Director, Cell Therapy Manufacturing will be responsible for the overall operational management of the Cell Therapy Manufacturing Facility, including supervising manufacturing supervisors and operators specific to gene-mediated and non-gene mediated autologous or allogeneic cell-based therapies, or human cells, human tissues, and cellular and tissue-based products (HCT/Ps. The candidate will oversee all day-to-day GMP operations, including project and timeline management, budget, personnel, P&L, facility management, and coordination with the Quality Control and Quality Assurance functions. They will be responsible for ensuring the Cell Therapy Manufacturing delivers all services in a timely, compliant manner, while staying within budget. The Associate Director, Cell Therapy Manufacturing will be a key leader in the organization and will have client-facing interaction with innovator company subject matter experts and senior management. The position will develop operational cadence and staffing structures permitting supervision of shifts that cover 24/7 cell therapy operations and the establishment of appropriate training and retention programs for manufacturing associates and supervisors.

Responsibilities

  • Start-up and lead Cell Therapy Manufacturing operations in newly constructed GMP facility.
  • Direct the day-to-day operations of the Cell Therapy facility and all associated activities through both hands-on leadership and supervision of Cell Therapy Manufacturing staff.
  • Work with their Process Development counterparts to develop and support the generation of SOP’s and Batch Records, and the Tech Transfer activities of new processes to the site.
  • Ensure all Cell Therapy Manufacturing resources, including production, facilities, and quality control, necessary to meet production goals in alignment with the objectives of the program scope of work.
  • Establish production scheduling processes and procedures defining the daily tasks of the Manufacturing Operators and support staff.
  • Ensure appropriate review of executed production batch records, and support deviations, CAPA’s, Change Controls and Investigations.
  • Responsible for sound project and financial management including preparation of and adherence to budgets and standards for cost measurement.
  • Work to ensure available capacity to meet the Center for Breakthrough Medicine’s goals.
  • Develop and implement policies and procedures that ensure production activities are compliant with all governing regulatory, environmental, and safety directives.
  • Support the scale-up and eventual commercial licensure of the Cell Therapy facility
  • Develop/build the scheduling team, system, tools, inputs, and resource requirements for the manufacturing of both clinical and commercial products.
  • Ensuring people have maintained the appropriate level of training necessary for Cell Therapy GMP manufacturing in a multi-product facility.
  • Collaborate with other Managers and departments on site and with colleagues across the Center for Breakthrough Medicines network
  • Ensure a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements and model these behaviors every day
  • Establish a dynamic and progressive culture within the organization that enhances the day-to-day experience of the team and is consistent with the vision and mission of The Center for Breakthrough Medicines.

Qualifications

  • Bachelor’s Degree in a relevant scientific discipline; Advanced Degree in biological sciences preferred.
  • Minimum 8 years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
  • 5+ years in a Manufacturing/Operations in a cGMP environment is required.
  • Technical writing, training curriculum development, and knowledge of operations scheduling preferred.
  • Cell Therapy manufacturing experience preferred.
  • Ability to work by influencing peers and their reports and gain their cooperation.
  • Lead teams focused on technical writing of SOPs, training curriculum creation and implementation, and scheduling while supporting the end user requirements.
  • A high sense of urgency and a commitment to delivering results is essential.
  • Ability to quickly adapt to a rapidly changing environment and demands
  • Experience in budget management and business development a plus

Compensation: TBD

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