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Senior Research Scientist
2 months ago
Job Summary:
NextCure Inc. is seeking a highly skilled and experienced Senior Scientist to join our Analytical Development and Quality Control (AD/QC) team. As a key scientific expert, you will be responsible for leading the resolution of scientific and technical challenges in the AD/QC group.
Key Responsibilities:
- Develop and apply molecular biological methods, and other state-of-the-art analytical technologies to analyze and characterize NextCure's products, their conjugates, and variants.
- Proven ability to work successfully in cross-functional teams and represent at various internal and external meetings.
- Strong background in implementing phase-appropriate assays for various analytical methods such as SEC, RP-HPLC, HILIC, IEX, CE-SDS, cIEF as well as ELISA and qPCR.
- Experience in developing and performing Liquid Chromatography-Mass Spectrometry (LC-MS) based methods to be used for characterization and/or GMP quality control of therapeutic proteins.
- Experience in cell biology (cell-based assay) and immunology, with application to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities.
- Proficient in analytical method development, qualifying assays, and validation.
- Routinely execute and review analytical assays for release of drug substance, drug product, in-process, and stability in GMP setting.
- Author/review deviations, SOPs, batch records, CAPAs, OOSs.
- Experience in drafting analytical sections of INDs.
- Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting.
- Demonstrate excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization.
- Guide and train team members and serve as the subject matter expert in physicochemical and biological assays.
- Knowledge of compendial assays is preferred.
- Experience in mentoring and scientific leadership is preferred.
Requirements:
- BS with 3-5 years of hands-on industry experience in developing and routinely executing physicochemical and biological assays using variety of analytical instruments including HPLC/UPLC.
- MS with 2-4 years of hands-on industry experience in developing and routinely executing physicochemical and biological assays using variety of analytical instruments including HPLC/UPLC.
Education:
- Bachelor's degree in the life sciences, biochemistry, or related field is required.
- Master's degree in life science, biochemistry, or a related field is preferred.
