Manager, Drug Product Tech Transfer

    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 late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

    We are currently preparing for large scale production and process validation and licensure of a vaccine against the SARS-nCoV-2 novel Coronavirus. To assist with this and other programs, we are seeking a Drug Product Tech Transfer Manager who is responsible for tech transfer to external CMOs, including management of manufacturing, release, and supply of clinical drug product (DP). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

    Responsibilities include, but are not limited to:

    • Responsible for drug product technology transfer activities from preclinical development through commercial supply
    • Identify, select and manage of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DP in support of ongoing clinical programs
    • Deliver robust, scalable and cost-effective manufacturing processes that meet or exceed the target clinical profile
    • Coordinate the execution of the validation of DP processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
    • Assist with the writing and reviewing documents for INDs / regulatory section submissions
    • Prepare, review, or edit cGMP batch records, CMC Regulatory, and Quality documents
    • Provide leadership for technology transfer, serving as the primary point of contact with the DP CMOs
    • Collaborate with other CMC team members to build and execute the CMC manufacturing plan
    • Work closely with global project managers at both Novavax and CDMO's to ensure project milestones are maintained

    Minimum Requirements:

    • MS or BS in engineering, chemistry, biology, or related discipline, plus at least 5 years of experience in aseptic drug product manufacturing operations
    • Proven experience in collaborating in matrix teams in a technical environment
    • Strong project management skills and ability at working collaboratively with cross functional teams
    • Strong interpersonal and communication skills
    • Knowledge of aseptic drug product manufacturing requirements
    • Experience in oversight of CDMOs for process development, characterization, technology transfer, manufacturing, and release
    • Knowledge of CMC development from pre-clinical through clinical to commercialization

    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: 610500407Posted: 2021-03-21Job Title: Drug Product Tech Transfer