About this role
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
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.