Analytical Development Associate Scientist
Overview: Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Analytical Development Associate Scientist to join our vibrant team at the National Institutes of Health (NIH), supporting the Analytical Development team within the Vaccine Production Program (VPP) of the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID). The position location is Gaithersburg, MD. ResponsibilitiesProvide analytical methods development to support NIAID Vaccine Research Center's vaccine product pipeline and monoclonal antibody projects.Provide centralized analytical development program, from sample testing, method development, and method transfer to investigations.Analyze unique problems involved with regulatory requirements and related scientific analysis. Interact with scientists from other organizations or institutions involved in similar or related research projects.Perform comparability assessments of bioanalytical techniques.Support Chemistry, Manufacturing, and Controls (CMC) activities for Investigational New Drug (IND) applications such as provide regulatory submission sections on physicochemical methods and comparability; resolve internal comments; and address regulatory agency questions.Design experimental approaches to provide critical evaluation of scientific data, mentor scientific staff and collaborate with other scientists; integrate and start-up new technologies within the laboratory. Draft and data verification of CMC sections of IND and BLA.Interact with students, post-doctoral fellows and non-doctoral research technicians on experimental design and laboratory-based methodologies.Perform analytical experiments with proteins using blotting techniques such as dot/slot and western blots; agarose and acrylamide gel electrophoresis procedures; high-throughput epitope-screening and characterization assays such as Octet biolayer interferometry; flow cytometry techniques and analysis techniques; immunological assays such as neutralization and ELISA assays.Perform physical chemical analysis including colorimetric content analysis, purity /impurity /affinity chromatography analysis, and enabling characterization analysis such as mass spectrometry and NMR, etc.Perform method development, optimization, and qualification for technology transfer, validation, and regulatory submission support.Provide analytical support for product specification, characterization, qualification assessment, and comparability.Perform in-process testing and analytical investigations for mAb and novel molecules. Coordinate with manufacturing Quality Control (QC) testing.Collaborate with process development, QC, and research teams to support pipeline advancement. Key CompetenciesHas developed background and skills necessary to contribute to research, development, or support programs in a timely manner.Establishes working relationships and credibility with project team members and others within the organization. Applies and interprets basic scientific principles, theories, concepts, and protocols.Makes observations, analyzes data, and interprets results.Develops solutions to problems within job scope where precedents exist.Self-reviews work for accuracy and soundness of technical approach.Prepares precise technical report summaries, protocols, quantitative analyses, and maintains appropriate documentation.Presents findings at internal meetings and/or contribute to the preparation of manuscripts and patent applications.Education RequirementsBS/MS in Biology, Biochemistry, Chemistry, Immunology, or related science discipline Benefits100% Medical Dental & Vision Coverage for EmployeesEducational Benefits for Career GrowthPaid Time Off (Including Holidays)Employee Referral BonusProfit Sharing401K MatchingTuition reimbursement and professional development opportunitiesFlexible Spending Accounts:Healthcare (FSA)Parking Reimbursement Account (PRK)Dependent Care Assistant Program (DCAP)Transportation Reimbursement Account (TRN)The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate. Accessibility: If you need an accommodation as part of the employment process please contact firstname.lastname@example.org Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual's assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.