Sr. Scientist, Quality Control
Sr. Scientist position in the Quality Control team at NextCure, Beltsville. MD
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 highly-motivated scientists with a deep interest in contributing to the delivery of biopharmaceutical therapies to the patients.
The team is involved in a wide-range of development activities spanning protein production, purification, 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
- Be an integral in all aspects of biopharmaceutical CMC development including purification, analytical development/characterization, formulation, compatibility, and fill-finish activities.
- Development and routinely run analytical assays to determine product quality (SDS-PAGE, Bioanalyzer/cIEF, HPLC methods such as SEC, IEX, CEX, RP-HPLC, ELISA, Octet).
- Plan and execute formulation and characterization studies.
- Analytical support for GMP manufacturing
- 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 MS/PhD in Pharmaceutical Chemistry and/or Biochemistry or related field.
- Possess 8+ years of industry experience in analytical development & characterization/formulation of protein based therapeutics.
- Have an in depth and working knowledge of protein chemistry concepts involved in protein purification, characterization and formulation.
- Have strong technical skill in analytical method development, validation, and QC testing in an GMP environment.
- Have experience using equipment such as HPLCs, Bioanalyzer/cIEF, Biacore/Octet, ELISA, etc.
- Have experience in authoring technical reports.
Be an independent thinker and possess a demonstrated increase in responsibility and impact within current and past roles.