Senior Scientist – Bioconjugation Process Development

25th January 2023

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The Bioconjugation Process Development Senior Scientist is responsible for leading bioconjugation downstream process development activities to support Abzena Bristol’s development and manufacturing operations. 

 

Responsibilities 

  • 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.    

Physical Requirements:    

  • 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.  

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