NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville focused on discovering and developing first-in-class immunomedicines for the treatment of cancer and other diseases. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development. We are excited about the ongoing work at NextCure and invite you to come join us in the culture and build your career in an environment that nurtures professional growth and development.
The team at NextCure is looking for highly-motivated protein chemists/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 including, formulation & analytical method development/characterization, pre-clinical and clinical study support and regulatory filings. The candidate will be expected to make significant contributions to ongoing analytical development and characterization activities to meet critical timelines and milestones for the company
· Provide leadership in analytical characterization of NextCure’s protein therapeutics utilizing biochemical and biophysical characterization methods.
· Develop and qualify new analytical methods.
· Evaluate industry best practices for product characterization and bring new analytical technologies to NextCure.
· Lead formulation development and characterization studies.
· Define and assess critical quality attribute (CQA) of products in development.
· Development and perform analytical assays to determine product quality (e.g., SDS-PAGE, Bioanalyzer/cIEF, HPLC methods such as SEC, IEX, CEX, RP-HPLC, ELISA, Octet, Mass spectrometry).
· Provide analytical leadership and subject-matter expertise in project teams
· Author relevant CMC sections for regulatory filings. Participate in addressing technical questions from regulatory agencies.
· Participate in internal scientific 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.
· BS/MS/PhD in Chemistry and/or Biochemistry or related field.
· Possess 5 or more years of industry experience in analytical development and characterization of protein based therapeutics
· Subject-matter expertise in protein chemistry concepts involved in, product characterization, formulation development and CQA assessment.
· Demonstrated proficiency in analytical assay development, qualification and validation.
· Hands-on experience using equipment such as HPLCs, Bioanalyzer/cIEF, Biacore/Octet, and Mass spectrometer
· Experience in authoring technical reports
· Be an independent thinker and possess a demonstrated increase in responsibility and impact within current and past roles.
· Experience of supervising and coaching junior scientific staff on analytical methods, instrumentation and assessment of product quality
· Experience of collaborating with Discovery and Research groups on aspects of product quality and analytical methods
· Experience working in a GMP environment is highly desired