Director/Senior Director, External Manufacturing Operations

    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/Senior Director, External Manufacturing Operations responsible for leading day to day contract manufacturing operations for supply of NVX-CoV2373 drug substance.

    Responsibilities include but are not limited to:

    • Manage, execute, and control the day-to-day engagement and communication with the drug substance CMOs to ensure their contractual obligations and mandates are delivered
    • Develop and implement a global strategic plan for the operation of the drug substance CMO facilities based on the projected demand plan, capacity of internal manufacturing, and other existing or developing business plans
    • Develop and implement a global strategic plan for maximizing reliable supply (i.e., meeting quality and yield key performance indicator goals) of drug substance within defined manufacturing network
    • Oversee financial and non-financial obligations and proactively address issues and mitigate risks
    • Coordinate and manage purchase requisition reviews with Legal, Finance, Supply Chain, and the CMOs to ensure timely approval and issuance of CDA, MTA, agreements/contracts, and purchase orders
    • Work alongside both the CMOs and internal teams to optimize communications/performance and develop strategic,long-lasting partnerships
    • Monitor monthly spend and contract requirements to ensure compliance
    • Oversee the annual budget planning process for the external DS manufacturing
    • Manage client relationships throughout the relationship lifecycle
    • Serve as a liaison between external CMOs and internal Manufacturing Sciences & Technology technical staff
    • Develop and facilitate the implementation of continuous improvement projects

    Minimum requirements:

    • B.S. in scientific or management degree
    • 15+ years of experience in progressive leadership roles: accountable for alliance management and cross functional relationships
    • Experience working with financial systems, budget tracking, review and approval of definitive contract agreements, contract terms & conditions, master service agreements, statements of work
    • Experience working in multicultural international environments
    • Experience with Project / Portfolio Management
    • Experience with Operational Excellence and/or continuous improvement tools
    • Excellent track record in Partner, Vendor, Account and Project Management
    • Excellent track record in managing cross functional teams
    • Needs to be self-driven, motivated and can work independently in a matrix environment with a continuous improvement mindset
    • Excellent verbal and written communication and presentation skills

    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: 612882476Posted: 2021-03-21Job Title: Senior Director External