Sr Scientist, Bioconjugation

Abzena Inc.•Bristol, PA

About The Position

The Bioconjugation Process Development Senior Scientist leads downstream bioconjugation process development activities supporting Abzena Bristol’s development and manufacturing operations. The role focuses on developing, optimizing, and scaling processes for conjugated biotherapeutics, including antibody-drug conjugates, conjugate vaccines, protein-oligonucleotide conjugates, peptide-protein conjugates, and chelator-antibody conjugates. The position involves hands-on execution of conjugation reaction work-up, chromatographic purification, membrane filtration, and bioanalytical characterization. The scientist serves independently as a technical lead and subject-matter expert for internal and external project communications, contributes to laboratory operations, and manages and supervises technical team line reports. The role also requires authoring and reviewing technical and quality documentation, maintaining knowledge of advances in bioconjugation and bioprocessing, and adhering to applicable quality standards, policies, and procedures.

Requirements

  • PhD, or BS/MS degree in biochemical sciences or bio-engineering with industry experience in biotherapeutic development or bioconjugation: more than 1 year with a PhD, or more than 3 years with an MS/BS.
  • Experience in preparative purification of biological molecules such as antibodies, carrier proteins, viruses, viral vectors, or other biological molecules.
  • Expertise in normal flow filtration and tangential flow filtration, including TFF and UF/DF.
  • Knowledge of bioprocess optimization strategies and experimental design (DoE).
  • Thorough hands-on experience with preparative chromatography systems such as AKTA Pilot, AKTA Ready, or AKTA Explorer, and manual or automated TFF skids.
  • Expertise in quantitatively determining scalable process parameters for normal flow filtration, tangential flow filtration, and preparative chromatographic separations.
  • Knowledge of cGMP manufacturing operations and GxP principles.
  • Strong knowledge of bioconjugation reactions, techniques, and approaches.
  • Experience with protein bioanalytical techniques such as HPLC, LC-MS, and UV-spectrophotometry.
  • Experience with large-scale bioprocess equipment, including pallet tanks, pumps, biowelders, biosealers, bio-rockers, and single-use assemblies.

Responsibilities

  • Operate to the highest ethical and moral standards and comply with Abzena policies and procedures.
  • Communicate effectively with clients, supervisors, colleagues, and staff; participate as a team player across the business.
  • Adhere to regulatory and Abzena quality standards, policies, procedures, and mission.
  • Perform other duties as assigned.
  • Contribute to laboratory operations, including instrument and equipment operation, material shipment preparation, and consumables procurement.
  • Develop downstream conjugation bioprocesses for conjugated biotherapeutics, including antibody-drug conjugates, conjugate vaccines, protein-oligonucleotide conjugates, peptide-protein conjugates, and chelator-antibody conjugates.
  • Collaborate on development, optimization, and scale-up of bioconjugation reactions, purification steps, and characterization approaches.
  • Perform chromatographic purifications, including affinity, hydrophobic interaction, and ion exchange chromatography; normal and tangential flow membrane filtrations; buffer and solution preparation; and conjugation reaction work-up.
  • Perform, develop, and optimize bioanalytical characterization of bioconjugate products using techniques such as HPLC, UPLC, LC-MS, MALDI, MALS, and colorimetric assays.
  • Author and review laboratory notebooks, process development reports, protocols, batch records, SOPs, and technical presentations.
  • Maintain technical understanding of advances in bioconjugation and bioprocessing through literature searches and review.
  • Serve independently as bioconjugation process development technical lead and subject-matter expert for internal and external project communications.
  • Manage and supervise technical team line reports.
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