In this vital role, you will contribute to our client's diverse process development portfolio of therapeutic modalities with a focus on understanding the process and product properties of large molecule drug candidates and assessing the quality attributes of protein therapeutics being developed across multiple therapeutic areas in our client pipeline.
Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate delivery of procedures and processes.
Responsible for analytical leadership of are pivotal programs, Scientific and technical expertise to advance the pre-pivotal portfolio Lead development and implementation of sophisticated analytical techniques.
Routinely craft experiments that lead to a fundamental understanding of a therapeutic protein’s attributes and stability characteristics.
Development and optimization of analytical methods (HPLC/UPLC, CE, and mass spec) to support lead candidate selection for different modalities at Dev MA, to improve method performance, and to increase efficiency and throughput at the pre-pivotal stage.
Deep understanding of product quality attributes and methodology to measure attributes and to ensure proper control strategy.
Optimally function as an Attribute S
Support drug substance and drug product process development, and protein characterization
Authoring regulatory documents. Understanding of regulatory expectations for analytical methods, control and stability strategy, and comparability.
Doctorate degree OR
Master’s degree and 4 years of directly related life science experience OR
Bachelor’s degree and 6 years of directly related life science experience
Ph.D. in biochemistry, chemistry, or other life science area plus 4 or more years of industry experience.
Strong lab skills to design and execute scientific experiments, interpretation of complex data, and deliver results.
Strong expertise in analytical method development, validation, and troubleshooting for using HPLC/UPLC, CE and mass spectrometry, etc.
Strong proven experience in separation sciences, protein chemistry, and/or mass spectrometry.
Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as fragmentation, deamidation, oxidation, partial reduction, etc.), and their characterization and quantification tools.
Prior experience authoring or contributing to regulatory filings.
Work independently in advancing projects and studies within required deadlines.
Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment.