Scientist – Biologics Analytical Sciences

Responsibilities

• Characterization of biological molecules, identify degradation pathways, and define critical quality attributes. Contribute to analytical method development, qualification, validation, and transfer activities. Primary techniques are High performance liquid chromatography (HPLC), capillary electrophoresis, spectroscopy and mass spectrometry.
• Maintain familiarity with scientific literature and apply new knowledge appropriately to projects.
• Convey complex and nuanced concepts to interdisciplinary teams through oral and written presentations, and reports.
• Work in collaboration with other scientists to advance the development of state-of-the-art techniques to characterize biopharmaceutical products, assays, and tools. Develop high-throughput and/or automated methodologies for sample preparation.
• Develop creative solutions to moderately complex problems.
• Document and communicate results in electronic laboratory notebooks, technical reports, and oral presentations.

Minimum Qualifications

• BS or MS in Chemistry, Biochemistry, Biology, or other related discipline, with industry experience (BS w/ 4+ years, MS w/ 2+ years), preferably in the animal health biopharmaceutical industry.
• Motivated self-starter with excellent communication (oral and written), interpersonal, and organizational skills.
• Experience in separation technologies including multiple modes for HPLC and capillary electrophoresis (e.g., SEC, RP-HPLC, IEX, icIEF, CE-SDS) for the analysis of complex proteins.
• Experience in developing, and validating biopharmaceutical analytical methods, including liquid chromatography (UHPLC), electrophoretic separations, and glycoprotein analysis.
• Candidate demonstrates a breadth of diverse experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
• Prepare comprehensive analytical reports and presentations, conveying findings to both technical and non-technical stakeholders.
• Strong problem-solving skills and a proactive attitude toward process improvement.

Preferred Qualifications

• More than 4 years of industry experience in developing, validating and transferring biopharmaceutical analytical methods.
• Strong understanding of protein structure, post-translational modifications (including glycans) and potential sequence liabilities (e.g oxidation, deamidation, and clipping).
• Familiarity with biopharmaceutical manufacturing processes, including cell culture, purification, and formulation.
• Proficiency in Empower and Chemstation chromatographic software.
• UHPLC, electrophoresis, spectroscopy method development experience.
• Skills and experience in experimental design, technical problem solving and continuous improvement.
• Experience and understanding of mass spec analysis of biological products using LC-MS.
• Experience in SDS-PAGE gel digestion for LC-MS protein identification.
• Familiarity in plate-based assays such as ELISA.