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.
The Process Engineer will be heavily involved in managing the full process from inception and requirements gathering through to validation, delivery and beyond ensuring our production platforms are well characterized and efficient and can scalably produce high-quality products. Work on identifying and executing continuous improvement projects on production products and processes.
• Work with a cross-functional team of Scientists, Automation Engineers, Software Engineers, and Operations experts to develop, deploy, and rapidly improve automation solutions in a fast-paced startup environment.
• Understand and capture the requirements of new products/processes and make them a reality.
• Design and execute studies and data gathering exercises for new and existing protocols
• Create analytical tools in order to better understand our instruments and processes
• Coordinate the execution of qualification and validation studies, ensuring we maintain tight control over what is shipped to customers
• Work with Synthego’s automation engineers to transition new products and processes from R&D to production and to improve cost and efficiency of existing processes
• Identify areas for technological or process improvement and coordinate multi-disciplinary teams to implement these changes.
• Mapping processes in detail, down to the individual wells/volumes, and ensuring they are efficient and robust, is not a chore; it’s a hobby. • Understand how important vital qualifications are to the life-cycle of a product - IQ/OQ/PQ • Able to analyze data from a variety of sources (machines/databases/people) and draw insightful conclusions in order to assist others.
Education & Experience
• B.S. or M.S. in a Life / Physical Science or Engineering
• 3+ years experience investigating, developing, and implementing new manufacturing processes and improving existing manufacturing processes
• Biology, Mechanical or Electrical Engineering, Software, or Process Design - you can follow a broad range of disciplines, and know-how to spot the gaps between them
• Willing and able to execute hands-on, perform experiments where necessary
• Must be comfortable in a range of software packages to perform modeling/analysis