The Bioconjugation Process Development Senior Scientist is responsible for leading bioconjugation downstream process development activities to support Abzena Bristol’s development and manufacturing operations.
Operate to the highest ethical and moral standards.
Comply with Abzena’s policies and procedures.
Communicate effectively with clients, supervisors, colleagues and staff.
Participate effectively as a team player in all aspects of Abzena’s business.
Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
Perform other duties as assigned.
Contribute to assigned laboratory operations including instrument and equipment operations, material shipment prepration, consumables procurement.
Focus on developing downstream conjugation bioprocesses to manufacture conjugated biotherapeutics including antibody-drug conjugates, conjugate vaccines, protein-oligonucleotide conjugates, peptide-protein conjugates, and chelator-antibody conjugates.
Work collaboratively in the development, optimization, and scale-up of bioconjugation reactions, purification steps, and characterization approaches for conjugate biotherapies.
Hands-on execution of chromatographic purifications (affinity, hydrophobic interaction, and ion exchange chromatography), membrane filtrations (normal and tangential flow filtrations), buffer and solution prepration, conjugation reaction work-up.
Perform, develop and optimize bioanalytical characterization (HPLC, UPLC, LC-MS, MALDI, MALS, colorimetric assays, etc.) of bioconjugate products.
Authoring and review of relevant documentation including laboratory notebooks, process development reports, protocols, batch records, SOPs, technical presentations.
Maintain strong technical understanding of advancements in bioconjugaiton/bioprocessing through literature searches and review.
Serve independently as bioconjugation PD technical lead and subject-matter expert for internal and external project communications.
Management and supervision of technical team line reports.
Qualifications/ Skills Required:
A PhD or BS/MS degree in biochemical sciences or bio-engineering with industry experience (>1 year + PhD, >3 years + MS/BS) in biotherapeutic development or bioconjugation.
Experience in preparative purification of biological molecules (antibodies, carrier proteins, viruses, viral vectors, or other biological molecules).
Expertise in normal flow filtrations and tangential flow filtrations (TFF, UF/DF).
Knowledge of strategies for the optimization of bioprocesses and experimental design (DoE).
Thorough hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.), and manual or automated TFF skids.
Expertise with quantitative determination of scalable process parameters for normal flow filtrations, tangential flow filtrations, 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 (HPLC, LC-MS, UV-spectrophotometry, etc.)
Experience with large scale bioprocess equipment (pallet tanks, pumps, biowelders, biosealers, bio-rockers, single-use assemblies).
Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) as needed.
Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
Frequently lift and or move objects up to 30 pounds.
Stand/walk during entire length of shift.
Use arms, hands and fingers to handle, feel or reach.
Ability to climb, balance, stoop, kneel, crouch, or crawl.
Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.