Analytical Scientist

Mantell Associates is partnered with a leading global CDMO who are searching for a highly motivated and skilled Analytical Scientist - Antibody Drug Conjugates, to join their Analytical team in New England.

The successful candidate will have expertise in LCMS (Liquid Chromatography-Mass Spectrometry) based characterization of complex bioconjugates, with a strong understanding of ADC structure and stability.

Analytical Scientist - Responsibilities:

• Exercise technical judgment in the planning, implementation, and analysis of experiments related to method development, validation, reference standard creation and qualification, forced degradation, product characterization, and compatibility studies in accordance with pertinent ICH regulatory guidelines
• Develop and optimize LCMS methods for qualitative and quantitative analysis of ADCs. Develop and validate quantitative LCMS methods such as: Drug-to-Antibody Ratio (DAR) determination; Payload quantification (free and conjugated forms); Linker stability and degradation profiling; Site-specific conjugation analysis
• Perform intact mass analysis, peptide mapping, drug-to-antibody ratio (DAR) determination, and payload identification
• Characterize ADCs for critical quality attributes including conjugation sites, linker stability, and degradation products
• Author test methods, protocols, reports, and regulatory documents as needed
• Provide support for development and cGMP manufacturing campaigns, ensuring compliance with regulatory requirements and documentation standards - including both in-process and release samples
• Adhere to safety and quality standards
• Communicate technical findings and results to both internal and external stakeholders, including clients and regulatory bodies
• Collaborate with chemistry development scientists, quality control and regulatory affairs teams to ensure successful project delivery
• Mentor and develop scientific staff. Ensure continued technical and professional growth of department members, encourage efforts towards excellence and knowledge sharing
• Possess strong communication (oral, written), organizational, and leadership skills
• Maintain and troubleshoot LCMS instrumentation (e.g., Orbitrap, Q-TOF, Triple Quad)

Analytical Scientist - Requirements:

• Ph.D., M.S., or B.S. in Analytical Chemistry, Biochemistry, Chemistry, Chemical/Biomedical Engineering, or other related scientific discipline
• Relevant experience in analytical method development, validation and characterization of bioconjugates. (PhD with 4+ years, MS with 6+ years, BS with 8 + years of experience
• 4+ years of hands-on experience in LCMS analysis of biologics, preferably ADCs
• Strong knowledge of protein chemistry, conjugation technologies, and biotherapeutic development
• Proficiency in any of the software tools for MS data analysis (e.g., Xcalibur, MassHunter, Skyline, Biopharma Finder)
• Well organized with good problem-solving skills, a high level of attention to detail and have a passion for delivering high quality data in a fast-paced environment
• Experience with regulatory submissions and GMP/GLP environments (preferred)
• Experience with various techniques used in the characterization of ADC’s such as capillary electrophoresis (CE-SDS) for ADC purity and size analysis, hydrophobic interaction chromatography (HIC) for DAR profiling, size-exclusion chromatography (SEC) for aggregation and stability studies, UV-Vis spectroscopy and fluorescence-based assays for payload quantification, and immunoassays (ELISA, ECL) for antibody detection (preferred)

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.