Novavax
  • 17-May-2021 to 16-Jun-2021 (EST)
  • Manufacturing
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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.  Novavax is 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. Novavax is 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 Drug Product Scientist responsible for understanding Parenteral aseptic processing as it relates to drug product manufacturing. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. Influence and implement the technical agenda within a multi-discipline technical environment. Work with peer leadership in a positive fashion to deliver on functional technical objectives, deviation reduction, specific product business plan, and quality objectives.

Responsibilities include but are not limited to:

  • Act as primary technical resource for vaccine drug product manufacturing.
  • Author regulatory submission documents.
  • Provide input into user requirement documents.
  • Assist with the selection of equipment that meets the present and future process needs.
  • Act as primary technical resource for isolator technology, formulation/compounding, filling processes and inspection.
  • Identify process issues and plan and implement process improvements.
  • Author and provide input into technical standard operating procedures.
  • Assess impact and document process deviations.
  • Assess process performance by monitoring and analyzing process/product.
  • Author and perform design of experiments activities to ensure the equipment and processes meet the requirements.
  • Write/prepare manufacturing instructions.
  • Prepare protocols and conduct process validation.
  • Provide technical coaching and floor support to manufacturing.
  • The development and implementation of process/technology improvements, and the day to day scientific support for the manufacturing operations.
  • Assess impact and document process deviations, troubleshoot processing issues.
  • Define critical parameters and evaluate process improvements
  • Assist in product site transfers as required.

Minimum requirements:

  • BS / MS pharmacy, chemistry, engineering or related fields.
  • 5-7 years' experience in pharmaceutical parenteral manufacturing (aseptic processing).
  • Exposure to aseptic manufacturing technique. Working understanding of sterile drug product development.
  • Basic understanding of commercial manufacturing equipment and knowledge of GMPs.
  • Excellent verbal & written communication skills.
  • Understanding of tech transfer process for aseptic manufacturing procedures.
  • Assessment Test(s) if applicable.
  • Knowledge of technical support (i.e. development, scale-up, validaton, quality control, registration, etc.) for vaccine pareneteral manufacturing operations is preferred.
  • Excellent verbal & written communications skills and proficiency in Word/Excel/Powerpoint is required.

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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