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Veranova · 6 days ago

Analytical Scientist - Anti Body Drug Conjugates

Devens, MA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $120K/yr

4+ years exp

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients for pharma and biotech customers. They are seeking a highly motivated and skilled Analytical Scientist to join their Analytical team, responsible for LCMS characterization of bioconjugates and ensuring compliance with regulatory guidelines.

BiotechnologyHealth CareManufacturingPharmaceutical

No H1B

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)

Qualification

LCMS analysisAnalytical method developmentBioconjugates characterizationProtein chemistryConjugation technologiesSoftware for MS data analysisProblem-solving skillsAttention to detailCommunication skillsLeadership skills

Required

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

Preferred

Experience with regulatory submissions and GMP/GLP environments

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