Principal Scientist, Analytical Development, Molecular and Cellular Biology

Employer
Novavax
Location
Gaithersburg, MD
Posted
Apr 20, 2017
Closes
Apr 21, 2017
Industry
Science
Hours
Full Time
Are you ready to work for one of Washington's Top Workplaces? At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life. We are seeking a Principal Scientist to join our Analytical Development department to lead the Molecular and Cellular Biology group. The qualified individual should have significant experience with molecular biology techniques for DNA, RNA, and protein quantitation and their application for biological analysis and characterization of protein or vaccine products. The candidate will take a leading role in establishing strategy, development and validation of molecular biology assays for testing vaccine products. The candidate will be expected to manage scientists and work efficiently with cross-functional teams. The candidate must have industry experience to qualify. Responsibilities include but not limited to: Lead and build team of professionals developing and validating molecular biology methods for DNA, RNA, and protein quantitation (eg PCR, PicoGreen, PERT, SRID) for biological analysis and characterization of recombinant protein vaccine products Define strategic group's goals Participate in cross-functional workflows and provide scientific guidance to teams Develop strategy and assays for process-related protein impurities of expression system for vaccine products Apply new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product biological characterization Perform method transfers to other groups and external partners Thoroughly analyze results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations for analytics Prepare and review standard operating procedures, method development reports, qualification/validation protocols and reports, and scientific journal publications and presentations. Write, edit, and review analytical sections of CMC regulatory filings Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology Present scientific findings at internal and external meetings Minimal Requirements: Industry experience with knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) PhD in biological science or biochemistry or molecular biology. Minimum of 5 years of experience in pharmaceutical, biologics, and/or vaccine development. Strong expertise in development of immunoassays or molecular biology techniques. Strong assay development skills. Demonstrated managerial experience as well as experience in building teams. Ability to manage a team of scientists, and develop and motivate scientists to achieve results Demonstrated leadership skills and capable of working collaboratively and cross functionally. Ability to critically analyze data using statistical tools and to compile and review technical reports. Ability to define priorities and process to get things done. Understanding of FDA regulatory requirements associated with analytical biological analysis and characterization and documentation of vaccine products. Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents. Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) is preferred. Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements. Good understanding of statistical tools and knowledge of DOE and QbD principles is preferred Strong communication, presentation, and writing skills. Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Our product pipeline targets a variety of infectious diseases with vaccine candidates currently in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus (EBOV). Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden and employs over 300 individuals dedicated to developing novel vaccines to address infectious disease. Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan. We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. Job Posted by ApplicantPro