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.
This role is responsible for planning, performing, analyzing, summarizing, reporting, and presenting experimental results related to Upstream Process development and optimization. This position works closely with external contract development and manufacturing partners. The scientist will also have oversight of external manufacturing of master and working cell banks as well as viral seed stock production, viral vector production, and scale-up. This role authors and reviews technical protocols and reports, drafts batch records and SOPs. The position will support regulatory filings including specifications, validation, comparability, trend analysis, risk assessment, and product quality attributes The ideal candidate should have successfully demonstrated viral vector process development, production, and analytics, as well as personal attributes including initiative, independent thinking and collaboration skills.Responsibilities
- Designs and implements viral vector strategies for upstream and downstream process development
- Hands-on work in the developing, executing, and optimizing of upstream (cell culture, scale-up, characterization) unit operations for viral vector production
- Support technology transfer into vector manufacturing
- Works closely with external partners on appropriate viral vector process and characterization studies to enable manufacturing
- Authors and reviews viral vector development and process protocols, reports, and batch records
- Supports virus analytical method development, qualification, transfer, and associated protocols/reports as needed
- Assists with viral vector product quality attribute assessment and scoring to identify critical quality attributes (CQA)
- Supports viral vector process and analytical sections for regulatory filings and response to questions
- Potential responsibility to lead a small team
- PhD in virology, virus bioengineering, gene/cell therapy, or related field with 2+ years of industry-related experience; or M.S. with 10+ years of related industry experience
- Knowledge and experience in viral vector production, purification, and analytics
- Proficient with large-scale mammalian cell culture and suspension cells
- Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
- Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Demonstrated ability to maintain detailed execution records and perform data analysis
- Knowledge or experience with viral vector manufacturing in the biotech industry
- Expertise in virus upstream and downstream process development, such as large-scale suspension cell culture, bioreactors, tangential flow filtration, column purification
- Experience with Design of Experiment (DOE)
- Experience with virus characterization, such as replication-competent virus (RCV), infectious virus bioassays and viral particle assays
- Experience with viral vector production, purification, and characterization
- Strong communication skills (e.g., clear and concise) and a team player
- Strong time and project management skills
- Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
- Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
- Takes ownership of the assigned project, consulting with management and peers
- Able to understand and interpret data/information and its practical application