Research Associate/ Scientist
NextCure is a biopharmaceutical company situated in Beltsville, MD, involved in discovery, research and development of novel therapeutic solutions to cancer that are at the cutting edge of the immune-oncology science. The Quality Control team at NextCure is looking for a highly-motivated research associate/scientist with a deep interest in contributing to the delivery of biopharmaceutical therapies to the patients.
The team is involved in a wide-range of activities spanning formulation & analytical development/characterization, pre-clinical and clinical study support and regulatory filings. The candidate will be expected to contribute to ongoing activities in an efficient and effective manner to meet critical timelines and milestones for the company
- Develop and routinely run analytical assays to assess product quality (SDS-PAGE, Bioanalyzer/cIEF, ELISA, Octet, and HPLC methods such as SEC, IEX, CEX, RP-HPLC).
- Analyze and interpret results for GMP release and stability testing.
- Create, review, and approve GMP documentation and ensure adherence to regulatory agency requirements.
- Be involved in all aspects of biopharmaceutical CMC development including manufacturing support, analytical development/characterization and fill-finish.
- Participate in internal discussions, author technical reports, present scientific data at meetings and maintain tight timelines.
The candidate is expected to have a strong motivation and commitment to developing his/her personal skill-set while contributing to the goals of the organization by continually improving and building their capabilities, efficiency, effectiveness, and practical implementation of state of the art technologies.
- Possess a BS/MS/PhD in Chemistry, Biochemistry, Chemical Engineering, or related field.
- Possess 2-5 years of industry experience in analytical method development & characterization of protein based therapeutics. Recent graduates with relevant experience may also be considered.
- Demonstrate attention to details and ability to work within an interdisciplinary team environment.
- Ability to manage multiple tasks concurrently and drive tasks to completion in a timely manner.
- Have a working knowledge of protein chemistry concepts involved in protein purification, characterization and formulation.
- Have experience using equipment such as HPLCs, Bioanalyzer/cIEF, Biacore/Octet, ELISA, etc.
- Have experience in authoring technical reports and SOPs.
- Be an independent thinker and possess a demonstrated increase in responsibility and impact within current and past roles.
Experience working in a GMP/GLP environment is a PLUS.