CBM

Full Time EE - Onsite

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.

Summary

This role is responsible for planning, executing, analyzing, reporting on, and presenting on studies related to gene editing and cell therapy process development. This position works closely with the Cell Therapy Process Development leader, and the client to understand, discuss, and deliver against defined objectives. This role authors and reviews technical protocols and reports, and procedures. The ideal candidate should have a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaboration skills.

Responsibilities

• Independent functioning as a bench scientist, capable of planning, executing, analyzing and reporting on studies related to gene editing and cell therapy process development.
• Independent manager of work, including sourcing of materials, use of equipment and space, time management, problem solving, and risk identification/escalation to meet objectives.
•  Strong team member and contributor to overall cell therapy process characterization, development and validation activities individually or in a team
• Design and validate novel strategies for autologous or allogeneic cell therapy platforms.
• Capability to be hands-on in laboratory work in developing, executing, and optimizing of cell therapy unit operations
• Authors, and reviews process development study protocols, reports, and batch records
• Collaborates with Analytical Development to meet testing needs
• Works closely with clients and technical team on appropriate process and characterization studies to enable manufacturing
• Leads product quality attribute assessment and scoring to identify critical quality attributes (CQA)

Qualifications

• BS (5+ years’ experience), MS (3+), or PhD in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic cell therapy (iPSC, NK or T-cells) technologies and demonstrated laboratory proficiency
• Extensive hands-on experience on gene editing technologies (CRISPR etc.) in human iPSC, NK, or T-cells and selection of edited clones & their characterization is required
• Knowledge and experience in stem cells (iPSCs or MSCs) reprogramming, culture and differentiation into various cell types
• Hands-on experience with most equipment and unit operations of cell therapy process development is highly preferred.
• Expertise in operating cell culture bioreactors at development or pilot scale is plus.
• Thrives in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
• Able to communicate project status, risks, needs, and data/information and its practical application to junior staff and management
• Flexible for occasional weekend work

Education & Experience

BS (5+ years’ experience), MS (3+), or PhD in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic cell therapy (iPSC, NK or T-cells) technologies and demonstrated laboratory proficiency