Senior Scientist / Scientist II - Analytical & Quality at NextCure Inc

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 / Scientist II to join our Analytical Development and Quality Control (AD/QC) team. This is an on-site position located in Beltsville, Maryland. Applicants must be able to report to the Beltsville office on a daily basis.The Senior Scientist / Scientist II 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 / Scientist II 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

• Utilize experience directly working for a related biotechnology industry company to contribute to the analytical development and quality control team
• Develop and apply molecular biological methods, and other state of the art analytical technologies to analyze and characterize NextCures 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

• Prior experience working directly for a Biotechnology or Biopharmaceutical company within a similar capacity required
• BS with 5-8 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 4-6 of hands-on industry experience in developing and routinely executing physicochemical and biological assays using variety of analytical instruments including HPLC/UPLC
• Prior experience performing quality audits and OOSs strongly preferred
• Placement at Senior Scientist vs. Scientist II level contingent upon holding experience at the high end of the range and demonstrated mastery of required skills
• Ability to work a full-time schedule in-office on a daily basis in Beltsville, Maryland

Education

• Bachelors degree in the life sciences, biochemistry, or related field is required
• Masters 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.