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

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.

The Scientist will be responsible for performing and managing analytical method development, validation, release, and additional assays needed to support cell and gene therapy client programs. The candidate will assist in advancing strategic and scientific direction for the department to establish analytical development, analytical method lifecycle management strategies, and implement novel technologies. The candidate should have experience in team leadership as well as knowledge and skills in analytical development.

Responsibilities

• Consistently demonstrate and model the highest levels of moral standards and ethical integrity
• Capture data accurately and timely, and maintain detailed records in compliance with applicable regulatory, safety, and environmental standards
• Demonstrate independent decision and problem-solving skills, particularly with conducting experiments and following documented procedures
• Write and review: methods, standard operating procedures, reports, analytical sections of works

·        Demonstrate expectational organizational skills, strong attention to detail and ability to multi-task

• Perform and coordinate testing to support analytical development, process development and manufacturing investigations, and across functional groups
• Provide flexible support to multiple and varied research projects

·        Demonstrate ability to learn quickly and to work under minimal supervision

• Be responsible for method development, validation, and transfer activities
• Transfer methods to partner functions, and represent the Analytical Virus Assay team in cross-functional meetings
• Automate new method development, and adapt existing methods for automation where possible

·        Oversee supply and materials ordering and inventory 

Qualifications

• BS Degree Required; advanced degree preferred 

·        Cell Biology/cryopreservation/cell banking experience

·        Virology (classic Virology and/or molecular virology) experience

• Experience in development of bioassays for cell therapy or gene therapy products, such as infectivity, tittering, replication competent recombinant viruses to be used in support of assay development work is preferred
• Technical writing experience preferred but not required
• Experience in gene therapy and GMP environment is strongly preferred