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.