Associate Director, Head of Pilot Operations
, PA, United States
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. CBMs 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. CBMs horizontal and vertical integration provides one source throughout a products life cycle.
CBMs 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 highly motivated Associate Director, Head of Pilot Operations to provide leadership and management for Pilot lab execution within Process Development. This role will be responsible for providing operational and technical oversight to a pilot lab team, as well as work with a multidisciplinary group of engineers and scientists within the organization to ensure the flawless execution of pilot runs. The ideal candidate should be experienced in manufacturing-scale execution for adherent and suspension bioreactors (200-500L) and corresponding downstream purification. The candidate must be comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities. This position requires excellent organizational skills and effective collaboration with cross-functional teams including Process Development, Supply Chain and Manufacturing, as well as the Client to accomplish deliverables for pilot-scale execution.
**Responsibilities**
* Manage team of scientists and engineers responsible for pilot lab execution with Process Development
* Lead collaboration with Viral Vector Process Development teams to understand and successfully scale benchtop operations to Pilot scale (comparable to GMP scale)
* Partner with Tech Transfer, MSAT, and Manufacturing departments to train on and transfer Pilot scale process to GMP Operations
* Manage material sourcing, equipment and lab utilization, and resourcing to meet client timelines
* Stand-up Pilot facilities and operations including the development and implementation of procedures, equipment, and processes
* Serve as a scientific and technical lead for risk identification/escalation and investigations related to pilot lab execution
* Provide technical guidance to scientists/engineers authoring protocols to support pilot-scale execution and pilot summary reports
**Qualifications**
* Experience with tech transfer, process development, scale-up, pilot and GMP manufacturing
* Knowledge and/or experience in cell culture, viral vector production, and purification
* Experience in managing scientists and engineers of varying experience levels
* Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
* Strong collaboration and interpersonal skills, including verbal and written communication, and ability influence
* Strong entrepreneurial skills including self-starter, solution-oriented, organized, emotionally intelligent, and strong soft skills
**Education & Experience**
Ph.D. in Chemical Engineering, Biotechnology, or equivalent life sciences field with 5+ years experience, MS with 7+ years, BS with 9+ years in Chemical Engineering, Biotechnology, or related field
Compensation: TBD
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