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Manufacturing Specialist

Company: Novavax
Location: Gaithersburg
Posted on: June 12, 2021

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 Manufacturing Specialist who is a highly motivated and versatile individual to fill a challenging yet rewarding role as we look to commission and validate the facilities to produce our novel vaccines. This role requires a diverse skill set to assist with a variety of technical, operational, and project responsibilities. Must be highly flexible and collaborative to drive cross-functional success at the site and coordinate with tech transfer teams.

Responsibilities include but are not limited to:

  • Provide technical support of GMP manufacturing operations and staff.
  • Author, revise, and review GMP supporting documentation (SOP's, Batch Records, Forms, etc.)
  • Lead and support continuous improvements to streamline manufacturing processes to enhance safety, efficiency, and compliance.
  • Identify and implement new materials, equipment, and procedures.
  • Assist with real-time investigation of process and equipment deviations.
  • Conduct and document detailed investigations.
  • Knowledgeable in root cause analysis tools and application of these methodologies.
  • Lead, participate, and collaborate effectively with cross-functional teams.
  • Author and review deviations and change controls.
  • Implement effective corrective actions and preventive actions related to equipment, process, facility, external vendors, and compliance.
  • Demonstrate high rate of QMS closure on time without filing extensions.
  • Track exceptional events.
  • Analyze and trend data to aid in the development or revision of department processes and procedures.
  • Analyze technical problems to contribute to development of new or modified processes involving manufacturing operations.
  • Participate in various project initiatives serving as manufacturing liaison to other departments and sites.
  • Effective review of protocols and summary reports
  • Perform other duties as assigned.
  • Demonstrate effective and timely communication.
  • Support internal and external audits and inspections.
  • Work closely with Technology Transfer groups to implement process changes and improvements.

Minimum requirements:

  • Bachelor's degree (engineering or biological science is preferred).
  • Minimum 5 years' experience in GMP pharmaceutical, biologics and/or vaccine manufacturing in a manufacturing role.
  • Demonstrates interpersonal, technical aptitude, and problem-solving skills.
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs) from development or commercial applications.
  • Knowledgeable of FDA regulations regarding the manufacture of biological including regulatory inspection experience.
  • Excellent multi-tasking, analytical, organizational, and leadership skills.
  • Excellent verbal, written, and interpersonal communication skills.
  • Ability to troubleshoot, identify root causes, and systematically resolve problems.
  • Proficient in Window based software to include Excel and Word. Ability to adapt to changing software programs.

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.

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Keywords: Novavax, Washington DC , Manufacturing Specialist, Other , Gaithersburg, DC

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