Title: Research Associate - III
Location: Oceanside, CA
Duration: 06 months
Essential Duties and Job Functions:
• Perform experiments pertaining to:
o Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods
o Scale-down/-up of biologics drug product processes
o In-use stability and administration
• Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters
• Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations
• Execute studies in support of drug product technology transfers to clinical and commercial manufacturing sites
• Be an effective communicator of ideas, project goals and results at departments/meetings in both written and presentation format.
• Be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.
Minimum Qualifications:
• A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline.
• A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc.).
• Previous experience interfacing with biologics drug product manufacturing sites and providing technical support during engineering runs/GMP operations is a plus.
Must Have Requirements/Skills:
• Experience working with Biologics molecules (proteins, mAbs); experience working with ADC is a plus
• Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis
• Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.) and UF/DF is a plus
