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Senior Scientist
2 months ago
NextCure is a clinical-stage biopharmaceutical company located in Beltsville, Maryland, focused on the discovery and development of first-in-class immunomedicines for the treatment of cancer and other diseases. We are committed to professional development in the context of learning, managing, and developing our employees. We create a unique environment for our employees, providing exposure to various facets of our operations to cultivate interdisciplinary career growth and development.
NextCure is seeking an experienced and highly motivated Senior Scientist to join our Analytical Development and Quality Control (AD/QC) team. The Senior Scientist in Analytical Development and Quality Control (AD/QC) will be a key scientific expert, responsible for leading the resolution of scientific and technical challenges in the AD/QC group. The role involves performing investigations, interpreting complex data, developing methodologies, and providing justified approaches to support products such as monoclonal antibodies, antibody-drug conjugates, and bispecific antibodies.
The Senior Scientist will be hands-on in the laboratory, performing various tests and experiments to ensure the scientific integrity and success of product development, qualification, unknown peak identification, degradation pathway analysis via stress studies, reference standard qualification, comparability studies, release and stability testing in GMP setting. The position will contribute to the strategy of selecting and implementing the assays to ensure the products are well characterized and under quality control guidelines. Additionally, the role requires building collaborative relationships, staying updated with industry trends, leading the team in decision-making and problem-solving processes and being able to achieve department goals.
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
Required Experience
- 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
NextCure, Inc. is committed to equal opportunity and affirmative action in employment. The company ensures non-discrimination in all its employment practices. Every qualified applicant is considered for employment without attention to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, status as a protected veteran, genetic information, age, or any other characteristic protected by law.
