Director, Data Science and CMC Statistics

    Updated 30+ days ago
    Gaithersburg, MD 20877
    Full-time, Part-time
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    Job Description

    Job Description

    If you find science, speed, and success exhilarating, you have come to the right place.

    Novavax, Inc.(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavaxis currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.Novavaxis a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

    We are seeking a Director, Data Science and CMC Statistics that will have the following responsibilities.

    Responsibilities include but are not limited to:

    • Lead team to support CMC functions with their data needs, turning data into insight, and helping to better understand the results of studies, and make data driven decisions
    • Support the CMC organization in how to intersect data, statistics, advanced analytics and most relevant digital solutions to develop, transfer, manufacture products, in compliance with regulatory requirements
    • Drive the identification and evaluation of new technologies and match to CMC business needs. Work with IT organization to integrate new digital technologies around big data, robotic process automation, natural language processing, machine learning/deep learning, PAT (process analytical technology) and APC (advanced process control)
    • Support CMC functions in process characterization and optimization, analytical method development, qualification and validation (regular and bioassays), bridging of assays and method transfer, formulation development and optimization, analysis of comparability assessments, establishment of specifications, and analysis of manufacturing data, etc.
    • Lead best practices for creation of robust DOE experiments, and analyze the experimental data generated from these studies to create predictive models
    • Apply quality by design concepts to study designs and guide the process, formulation, and assay development
    • Support and coach organization in the use of applied statistics including study designs, sample size, mathematical modeling, etc.
    • Leverage historical data to set acceptance criteria and process ranges
    • Apply statistical methodologies to evaluate outliers, stability trends, expirations dates, and more.
    • Support the data alignment of processes, assays, and technologies across the company sites and external partners
    • Lead and coach the team to efficiently and effectively deliver high quality results

    Minimum requirements:

    • Advanced degree in Engineering, Biotechnology, Statistics, Computer Science, or related field with a minimum of 10 years of industry experience and a minimum of 5 years of CMC statistics experience
    • Experience in applied statistics supporting all CMC functions including process development, analytical development, formulations, manufacturing, quality control, etc.
    • Strong collaborative, team-oriented leadership, and management skills
    • Advanced skills using programs such as JMP, SQL, data visualization tools, and Alteryx
    • Hands on experience with digital product development, product evaluation and implementation
    • Demonstrated strategic, analytical and critical thinking, initiative, organization of information, and learning agility
    • Ability to influence, challenge thinking and gain credibility with senior leaders across the company
    • Excellent organizational skills, project management and attention to detail
    • Excellent communication and presentation skills with ability to communicate/translate complex concepts to non-technical audience
    • Familiar with regulatory guidance and FDA guidelines

    Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

    Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

    Equal Opportunity Employer/Veterans/Disabled

    Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

    Job Posted by ApplicantPro
    Posting ID: 612881108Posted: 2021-03-21Job Title: Statistic