To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com or give me a call at (425)-298-1474. Thank you!

Pay rate: 40 - $45/hr.

Industry: Pharmaceutical

Key Responsibilities:

• Support the biologics characterization and stability assessment activities of the assigned biologics, including candidate screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins.
• Execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
• Prepare concise and sound scientific presentations of experimental results to the management and assist in authoring detailed scientific technical reports.
• Stay current with the scientific literature and support new scientific initiatives.

Qualifications

• A Bachelor’s degree with typically 4 years, or a Master’s degree with typically 2 years of relevant experience in a scientific field.
• Extensive hands on expertise using analytical methods for chemical and structural characterization of biologics e.g. HPLC, UPLC, capillary electrophoresis, particle analysis, and other biophysical techniques (UV-vis, DLS, DSC, etc.) for protein characterization is a requirement.
• Scientific understanding of the structure & function of monoclonal antibodies, antibody constructs/conjugates, bispecifics, and fusion proteins and their modes of degradation/stabilization.
• Strong laboratory skills focused on formulation development for monoclonal antibodies and antibody constructs/conjugates (standard excipient selection, functional excipients, high throughput assays).
• Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.