Sr. Research Associate, Biologics Formulation Development
Participates in developing formulations for stable and releasable PEG-protein therapeutics. Designs and conducts pre-formulation and formulation development studies for parenteral liquid and lyophilized biologic drug products to ensure stability and manufacturing feasibility for pre-clinical and clinical trials. This position contributes to and supports the company’s research and product development efforts to create high value therapeutics to address unmet medical needs.
Responsible for design and development of new biologics drug formulations. Also responsible for formulation optimization with a view to establish the quality and stability of drug products. General responsibilities include:
• Design and conduct biologics formulation development experiments, either independently and / or in a collaborative environment.
• Perform sample analysis with biochemical and biophysical assays including HPLC, CE-SDS, cIEF, KF, particle analysis.
• Write experimental plans / protocols and technical reports
• Accurate and timely documentation of scientific work; analysis, interpretation and preparation of data for presentation; assist in generating technical reports.
• Assist in maintaining general laboratory functionality and safety, including ordering/receiving lab supplies and lab equipment maintenance.
• Other relevant duties
• Bachelors or Masters degree in a related scientific or engineering discipline. Equivalent experience may be accepted.
• A minimum of 6-8 years of work experience in research and/or development environment, preferably in bioassay, biochemistry or biologics formulation develoment (6 years for Masters and 8 years for Bachelors.)
• A solid understanding of protein chemistry, degradation / stabilization mechanisms and formulation development.
• Experience with standard analytical characterization techniques for biologics (SEC, IEC, CE-SDS, cIEF, RP-HPLC, particle characterization), assay troubleshooting and data interpretation.
• Demonstrated excellence in written and verbal communication, time management and working as part of a team.
• Good computer skills and working knowledge of Microsoft Office.
• Experience with biologics drug product process (e.g. filtration, lyophilization) and working in a GLP or GMP environment are a plus.