CBM

Full 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

Your responsibilities as a Senior Scientist on the Mass Spectrometry Analytical development team include developing and routine testing mass spectrometry assays, to support the Cell Therapy program.

The successful candidate needs to have a solid understanding of Cell and Gene Therapy Production, as well as high-throughput and automated analytical assay development skills. The candidate will responsible for Assay development, qualification, implementation, and transfer to quality control, both manually and automated using LC/CE and LC-MS.

Responsibilities

·        This is a lab-based/hands-on role where you will join a diverse team at the Center for Breakthrough Medicines (CBM) to support the Cell and Gene Therapy Programs

·        The Senior Scientist will be responsible for executing and developing analytical strategies in support of the Analytical testing platform at CBM Gene and cell therapy programs.

·        Routine analytical testing for separation (LC, CE, and LC-MS) based assay for in-process, stability, characterization, release assays, purity, strength, potency, drug substance, and drug product samples.

·        Developing analytical testing using (LC, CE, and LC-MS) based assays to support in-process sampling, drug substance, and drug product samples as well as stability, characterization, release, and purity.

·        Extensive experience and understanding of mass spectrometric various techniques in implementing LC-MS methods using Orbitrap, and TOF for intact mass analysis, peptide mapping, and post-translational modification

·        Capable of developing and implementing absolute quantification LC-MS/MS methods for different biological matrices as well as quantitative LC-MS/MS methods (LOD, LOQ, confidence intervals, etc.)

·        Strong hands-on UPLC and high-resolution mass spectrometry, troubleshooting, and maintenance

·        Cross-functional collaboration with Vector- and Cell-Analytical Development & Translational teams for method transfer, translating manual or low throughput separation-based assay (LC, CE, and LC-MS) into the HTP (High-throughput) or automated methods.

·        Collaborating cross-functionally with Vector- and Cell-Analytical Development & Translational teams for method transfer from manual or low-throughput assays (LC, CE, and LC-MS) into the HTP (High-throughput) or automated methods.

·        Demonstrated ability to bring innovations and creativity to the analytical testing and team player.

Qualifications

·        Ph.D. in Analytical chemistry, biochemistry, or related field with 5 - 7 years of experience in analytical assay development in CGT in the biotech/biopharmaceutical industry.

·        Hands-on experience in setting up top-down and bottom-up, peptide mapping mass spectrometry analyses of biotherapeutics, beside

·        Developing analytical methods in compliance with ICH guidelines.

·        Must be able to work in a fast-paced environment

·        Extensive experience in developing LC-MS, CE-MS, and LC-MS-based assays to test the quality of AAV vectors or other viral vectors used for gene therapy

·        Hands-on experience in separation-based technologies and platforms LC-MS (Thermo, Waters, Bruker) including nano-flow &HRMS

·        In-depth understanding of various Mass spectrometry quantification technologies

·        Experience with robotic liquid handlers (for automated sample preparation.

·        Experience designing a proof of concept studies using literature.

·        Experience writing technical documents including technical reports, and qualification protocols and reports.

·        Outstanding communication and presentation skills with the ability to work well as part of a multidisciplinary team; detail-oriented, multitasking, goal-oriented, timeline-oriented, and critical thinker.

·        Maintain excellently written documentation of completed experiments (ELN, LIMS) and maintain knowledge share systems (MS-Teams and Share Points).