Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field; M.S. with 2+ years or B.S. with 4+ years of relevant experience.
Extensive hands-on experience with LCUV characterization of biologics and ADCs.
Proficient in analytical techniques such as RPLC/UV, SEC-UV, IEX-UV, and cIEF.
Strong grasp of protein chemistry and conjugation technologies.
Familiarity with data analysis software like Waters Empower or similar.
Excellent technical writing and communication skills.
Responsibilities
Lead the development and optimization of chromatographic methods for ADCs and bioconjugates.
Design and execute studies for characterization of proteins, peptides, and conjugated species.
Conduct DAR analysis, aggregation, and stability studies.
Support analytical investigations related to process development and product quality.
Collaborate with cross-functional teams to establish analytical control strategies.
Develop sample preparation workflows for chromatographic analyses.
Interpret analytical datasets and communicate findings effectively.
Author technical reports and regulatory documentation.
Benefits
Opportunity to work on cutting-edge bioconjugate therapeutics.
Collaborative environment with cross-functional teams.
Involvement in regulatory submissions and clinical development programs.
Access to advanced chromatographic technologies and methodologies.
Professional development opportunities in a growing field.
Full Job Description
We are seeking an experienced separations scientist to develop methods for 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 separations-based characterization and method development across process development and CMC activities
The successful candidate will play a key role in developing and implementing advanced chromatographic workflows for structural characterization, impurity analysis, linker-payload assessment, DAR determination, and comparability studies to support clinical development programs.
Responsibilities
Lead development, optimization, and transfer of chromatographic analytical methods supporting ADCs and related bioconjugate therapeutics.
Design and execute chromatographic 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, aggregation, fragmentation and charge variant assessment, 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).
Develop robust sample preparation workflows for proteins, peptides, oligonucleotides, and conjugated modalities for chromatographic analyses.
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.
Maintain instrumentation including general maintenance, troubleshooting and scheduling of performative maintenance and vendor repair services.
Qualifications
Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 0 years of industry experience; M.S. with 2+ years or B.S. with 4+ years of relevant experience.
Extensive hands-on experience with LCUV characterization of biologics, ADCs, or related conjugated therapeutics.
Experience with analytical characterization techniques including RPLC/UV, SEC-UV, IEX-UV, non-reduced/reduced cIEF.
Strong understanding of protein chemistry, conjugation technologies, and biopharmaceutical analytical development.
Experience with data analysis software such as Waters Empower or equivalent platforms.
Excellent technical writing, problem-solving, and communication skills.
Preferred Qualifications:
Experience specifically supporting ADCs, AOCs, radioconjugates, or oligonucleotide therapeutics.
Familiarity with linker-payload chemistry and conjugation process development.
Knowledge of regulatory expectations for biologics and conjugated therapeutics.
Experience supporting method qualification, validation, and comparability studies.
Demonstrated experience supporting CMC development and CGMP environments.
Prior experience working with CDMOs and external analytical laboratories.
FLSA: Exempt
About Abzena plc
Abzena is a life sciences group with headquarters in Cambridge, UK and offices in the US and Japan. The company provides technologies and complementary services to enable the development and manufacture of biopharmaceutical products. Abzena's services and technologies are used by a range of companies and academic organisations across the pharmaceutical industry, including small biotech to large pharmaceutical companies. The company's proprietary technologies include composite human antibodies and site-specific conjugation technologies, which enable the development of antibody drug conjugates (ADCs) and other biotherapeutics. Abzena's services include antibody discovery and engineering, immunology services, bioassays, cell line development, and biomanufacturing. The company has a range of partnerships and collaborations with pharmaceutical companies and academic institutions, and has a number of products in clinical development.
