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.
· 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.
· 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 preferred
· 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).