Analytic Scientist/Senior Scientist
BioAnalytix works with leading biotherapeutic companies in the development and application of advanced analytics and data analysis of complex biologics, from candidate selection through regulatory package development. Applying state of the art mass spectrometry, biophysical analytics, and method development expertise, our team of PhDs provides precise data packages for specific project needs through all stages of biotherapeutic drug development, and we further offer our insights and understanding of CMC and regulatory requirements to support product development from IND through BLA.
In this key scientific role we are looking for a candidate with strong expertise in advanced LC-MS techniques and related biologic sample preparation methodologies, particularly as related to biopharmaceutical drug development. The candidate will also be able to build highly successful relationships with scientific team members both within BioAnalytix and with leading pharmaceutical partners and customers.
• Successfully design and execute advanced analytic studies on complex biologics using high performance LC-MS based platforms and related sample preparation approaches
• Identify key areas of scientific opportunity and risk; communicate, plan and implement solutions with team members
• Collaborate with internal & external scientific teams in study design, execution and delivery
• Generate project results to enable successful delivery of project plans, milestones and timelines
• Participate in the development of analytic data and methods for regulatory packages in biologic drug development
• Prepare, review and present project progress, results and analysis both internally and externally
• Documents experiments, results and findings in laboratory notebook and LIMS system;
• Must be able to lead execution of experiments independently
• Master or PhD degree in analytical chemistry, biochemistry, biophysics or pharmaceutical chemistry with 3-5 years of biopharmaceutical or related CRO industry experience. Title will float based on experience level.
• The ideal candidate should have direct experience in analytical development in the field of biologics, gene therapies or vaccines.
• Hands-on experience and in-depth understanding of protein characterization using LC-MS (e.g. Thermo QE series, etc) and associated bioinformatics (e.g. BioPharma Finder, etc) is required.
• Familiarity with additional chromatographic (e.g. SEC, IEX) and/or electrophoretic (e.g. CE-SDS) approaches is a plus.
• A strong background in bioanalytical chemistry, assay development, in-depth protein and/or glycan characterization, including product and process related impurities identification and quantitation.
• Experience with analytical method qualification, transfer, validation and general understanding of regulatory requirement (cGMP) for biotherapeutics development is a plus.
• Enthusiasm in science with a motivation of making contributions in a team environment.
• We hire for attitude and train for task!