Sr Scientist, Separations

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.