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Novavax, Inc. Manager/Senior Manager, External Drug Product Manufacturing Operations in Gaithersburg, Maryland

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 an individual to join our team as the Manager/Senior Manager, External Drug Product Manufacturing Operations. External Drug Product (DP) Manufacturing (Sr. Manager/Director level), responsible for leading day to day operations, managing strategic needs, and ensuring execution of deliverables across the DP Contract Manufacturing Organization (CMO) network.The ideal candidate will be a highly motivated individual with experience and interest in working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities who can work effectively in a dynamic atmosphere with a high degree of flexibility and creative problem-solving approach. The candidate will collaborate both internally and externally, offering visibility and an opportunity to directly contribute to the company's success.This person will report to the Senior Director, Drug Product Manufacturing.Responsibilities include but are not limited to:Development, execution, and management by:Serve as the main point of contact with DP CMOs for cGMP manufacture and supply of DP in support of ongoing clinical programs and commercial launch.Work with the DP CMOs and internal teams to optimize communications and establish efficient meeting structures in order to monitor performance and develop strategic,long-lasting partnerships.Manage, execute, and control the day-to-day engagement and communication with the DP CMOs to ensure their contractual obligations and mandates are delivered and KPIs are met.Oversee financial and non-financial obligations and proactively address issues and mitigate risks at the DP CMOs.Coordinate and manage CMO Purchase Orders to ensure adherence with departmental budget.Serve as a liaison between the DP Tech Ops team and the DP CMOs to ensure operational execution of tech transfers and other projects.Develop and facilitate the implementation of continuous improvement projects.Lead a product team with professionals from e.g., Supply Chain, QA, Manufacturing Support, Manufacturing Science and Technology and Regulatory.Contribute to writing and/or reviewing manufacturing instructions, annual product quality reviews (APR/PQR), applicable sections in registration files and variations, internal and external SOPs, qualifications, and validations.On occasions be involved in or lead sourcing, tech transfers, scale up and validation of drug substance processes as wells as developing supply and quality agreements.Minimum requirements:MS or BS in engineering, chemistry, biology, or related discipline.8+ years of experience in pharmaceutical or biological operations focused on late phase process transfer, pre-approval inspection, and clinical/commercial manufacturing.Experience in oversight of CMOs for process optimization, cha