Scientist I, Bioconjugation

Description

Scientist I - Bioconjugation is responsible for developing processes of client projects contracted with GBI. This position will be focused on developing processes for bioconjugation that are transferrable to GMP operations and meet client goals. The position will be a direct client interface representing GBI as needed. Deliverables of the Scientist I include experimental plans, reports, scale-down models, and process characterization required to support client IND and BLA submissions.

Specific Duties

• Perform bioconjugation synthesis, develop verification plan, execution, and report including technical transfer package to the GMP team.
• Good understanding of regulatory compliance and guidelines (e.g. FDA, EMEA, and ICH).
• Monitor results, identify problems and develop solutions. Update clients on the project progress and able to discuss technical challenges, studies analysis, and conclusions.
• Development, planning, and execution of pre-GMP scaled process run/toxicology material.
• Establish a Bill of Materials list for new processes and maintenance of laboratory inventories and equipment.
• Willingness to work with controlled substance molecules.
• Write and/or review technical reports such as SOPs, experimental plans, interim project status reports, and summary reports.
• Ability to perform complex data analysis.
• Record all laboratory activities and results in appropriate notebooks.
• Effectively interact and assist other groups within the Development groups (Cell Culture, Protein Purification, and Bio-Conjugation) and the Quality/Regulatory and Manufacturing groups on process-related matters.
• Must be able to manage multiple projects.
• Maintain an up-to-date inventory of lab supplies and order materials, as necessary.
  
  

Requirements

Master of Science (MS): in protein chemistry, biochemistry, or organic chemistry

• 2+ years of relevant laboratory experience in Organic Synthesis/Bioconjugation, and bio-conjugation processes and development.
  
  

Bachelor of Science (BS): protein chemistry, biochemistry, or organic chemistry

• 5+ years of relevant laboratory experience in Organic Synthesis/Bioconjugation, and bio-conjugation processes and development.