CBM

Part Time EE

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

TDL’s Center for Breakthrough Medicines is seeking a highly motivated and independent researcher to lead a group of scientists focused on establishing purification strategies for Adeno-Associated Virus, Lentivirus, and Adenovirus (AAV, LV, and Ad) viral vectors in order to build best-in-class viral vector manufacturing technologies. The Sr. Scientist/Principal Investigator will play a key role in establishing viral producer/packaging cell lines and evaluating other manufacturing technologies. This position will also be responsible for the development of up-stream processes related to viral production and cell line engineering. It is expected that the candidate will have a working knowledge of viral-based production technologies and quality control (QC) techniques and employ design of Experimentation (DoE) to support their work. The Senior Scientist/Principal Investigator position in the Vector Engineering and Manufacturability group at the Discovery Labs offers an exciting opportunity to develop viral purification and analytical strategies for Gene and Cell Therapies to treat many diverse unmet medical needs.

Responsibilities

• Conduct technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell and gene therapy programs

• Advance scientific understanding of gene and cell therapy products by applying state-of-the-art genomic and cellular analytics research techniques and leading studies that aim to deepen product understanding

• Provide scientific and technical guidance and serve as SME for flow cytometry, molecular, virology and/or cellular analytical capabilities

• Support product development teams to ensure robust data analysis, solid cGMP method implementation, and broad incorporation of analytical strategy within Analytical Development and cGMP Testing Operations

• Support the design, development, and qualification of analytical methods to assess product identity, purity, quality and potency

• Assist in various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, Testing, Process Development, Clinical and Commercial Manufacturing, and Quality teams

• Provide scientific guidance to development operations, and clinical and commercial QC teams. Maintain current awareness of cGMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future Cell and Gene Therapy Development operations and product

• Responsible for building a highly efficient team capable of handling tight timelines while delivering high quality data

• Work independently to design, organize, and execute both short- and long-term research strategies

Qualifications

• MS/PhD in biology, virology, molecular Biology, or related discipline with 5+ years R&D/analytical development experience or PhD with 3+ years analytical development experience

• Previous industry or academic experience in cell and gene therapy, CAR-T research and development is preferred

• Expert level knowledge of design of experimentation (DoE); as well as be familiar with analytical QC assays including qPCR/ddPCR, silverstain/western blotting, ELISA, and imaging.

• Technical experience in flow cytometry, molecular biology, virology and/or cell-based potency methodologies

• Ability to handle large data sets to support -omics & -seq in conjunction with a base-knowledge of NGS technologies.

• Solid understanding of AAV/LV/Ad virus biology is highly preferred.

Competencies

• Strong communicator capable of delivering data-based reports in all relevant formats

• Strategic thinker with excellent problem-solving skills