Senior / Principal Scientist, LCMS - ADC & Related Modalities

Abzena Inc.•Bristol, PA

3d•Onsite

About The Position

With extensive experience in developing biologics and bioconjugates, Abzena offers a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, they find the best solution and use the right technologies to design, develop and manufacture products to ensure vital medicines are delivered to patients quickly and safely. Abzena is dedicated to quality excellence and driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. Abzena is more than a CDMO, they are a responsible and dedicated partner that takes care of products from concept to patient. This role is for an experienced LC-MS scientist to lead LC-MS method development and conjugate characterization activities supporting process development of antibody-drug conjugates (ADCs), oligonucleotide conjugates, radioconjugates, and other complex bioconjugate modalities. This individual will serve as a technical expert in mass spectrometry-based characterization and method development across process development and CMC activities. The successful candidate will play a key role in developing and implementing advanced LC-MS workflows for structural characterization, impurity analysis, linker-payload assessment, DAR determination, peptide mapping, and comparability studies to support clinical development programs.

Requirements

Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 5+ years of industry experience; or M.S. with 8+ years of relevant experience.
Extensive hands-on experience with LC-MS characterization of biologics, ADCs, or related conjugated therapeutics.
Strong expertise in high-resolution mass spectrometry techniques and interpretation of complex datasets.
Experience with analytical characterization techniques including intact mass analysis, peptide mapping, IEX, SEC, RP-HPLC, CE, and native MS.
Demonstrated experience supporting CMC development and CGMP environments.
Strong understanding of protein chemistry, conjugation technologies, and biopharmaceutical analytical development.
Experience with data analysis software such as Waters Connect, MassLynx, or equivalent platforms.
Excellent technical writing, problem-solving, and communication skills.

Nice To Haves

Experience specifically supporting ADCs, AOCs, radioconjugates, or oligonucleotide therapeutics.
Familiarity with linker-payload chemistry and conjugation process development.
Experience with multi-attribute methods (MAM) and advanced characterization workflows.
Knowledge of regulatory expectations for biologics and conjugated therapeutics.
Experience supporting method qualification, validation, and comparability studies.
Prior experience working with CDMOs and external analytical laboratories.

Responsibilities

Lead development, optimization, qualification, and transfer of LC-MS analytical methods supporting ADCs and related bioconjugate therapeutics.
Design and execute mass spectrometry studies for characterization of intact proteins/antibodies, fragment antibodies, small format proteins, peptides, linker-payloads, oligonucleotides, and conjugated species.
Perform characterization activities including DAR analysis, peptide mapping, PTM identification, conjugation site analysis, aggregation and fragmentation assessment, disulfide scrambling, free payload and linker impurity analysis, and stability studies.
Support analytical investigations related to process development, manufacturing deviations, comparability, and product quality assessments.
Collaborate closely with process development, bioassay, formulation, and quality teams to establish analytical control strategies and critical quality attributes (CQAs).
Serve as technical SME for high-resolution mass spectrometry platforms including QTOF, triple quadrupole, and associated LC systems.
Develop robust sample preparation workflows for proteins, peptides, oligonucleotides, and conjugated modalities.
Interpret complex analytical datasets and communicate findings to cross-functional project teams and client sponsors.
Author technical reports, analytical development summaries, regulatory documentation, SOPs, protocols, and method qualification reports.
Support regulatory submissions including IND, BLA, and IMPD analytical sections.
Evaluate and implement emerging MS technologies and analytical innovations to enhance characterization capabilities.
Mentor junior scientists and contribute to scientific strategy and laboratory best practices.