BioEngineer II/III


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.**

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 Bioengineer II, MS&T Technical Services who will support drug substance CMC-related activities across the Novavax product portfolio, including tech transfer, manufacturing, and supply of clinical and commercial drug substance (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a growing entrepreneurial environment with broad responsibilities and opportunities. Partnerships with global DS manufacturing at sites outside the US will/may require significant travel. The candidate will collaborate internationally, offering visibility and opportunity to directly contribute to the company's success. This role will be critical in ensuring establishment of robust operations and governance across multiple CMC functions to meet critical deliverables.

**Must be flexible and open to significant domestic or international travel, as well as shifted work hours to cover communication with international Manufacturing Sites**

Responsibilities include, but not limited to:

  • Responsible for providing drug substance manufacturing support for clinical development through commercial supply.
  • Provide MS&T presence at manufacturing sites as required to support global activities and specifically to deliver robust, scalable and cost-effective manufacturing processes that meet or exceed the target quality product profile.
  • Builds and manages technical relations at manufacturing sites to ensure that operational and technology transfer activities are performed consistently, completely and compliantly.
  • Engage cross functional collaboration with Quality Control and Quality Assurance to ensure that manufacturing sites are applying systems and processes in compliance with Corporate Quality systems and all relevant regulatory standards.
  • Support all elements of manufacturing site planning processes, production scheduling, manufacturing processes to deliver DS supplies on time in full.
  • Review and/or approve tech transfer protocol/reports, manufacturing batch records and Quality Notifications.
  • Facilitates communication between Manufacturing site and global resource as needed for production support.
  • Collaborates with Supply Chain to ensure Bill of Materials are routinely updated and forecasted for critical material supplies.
  • Review and report process performance based on Key Performance Indicators and CPV (as appropriate).
  • Review process comparability or quality risk assessment documents during transfer and process validation; provide input to control strategy based on site specific requirements.
  • Work with technical SME to review execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
  • Support preparation of CMC modules for regulatory submissions.
  • May provide hands-on technical/team support for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions.
  • Collaborate with Quality and other CMC team members to ensure consistent application of Quality governance and performance review.
  • Significant travel required, both domestic and international (up to 50%).

Minimum requirements:

  • MS or BS in engineering, chemistry, biology, or related discipline.
  • BS with 5+ years or MS with 3+ years of experience in pharmaceutical or biological operations focused on late phase process transfer, pre-approval inspection, and clinical/commercial manufacturing
  • Knowledge of CMC development from clinical through commercialization
  • Understanding of FDA/EMA/MHRA regulatory requirements associated with manufacturing of vaccine products.
  • Experience in oversight or implementation of technology transfer, process optimization, characterization, and/or commercial operations is beneficial.
  • Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, protein production, harvest, downstream purification and common analytical tools is preferred.
  • Strong project management and change management skills. Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
  • Strong interpersonal and communication skills with proven cross-functional collaboration experience in a technical environment
  • Capable of performing multiple functions in a fast-paced environment. Strong technical writing and good organization skills are required.
  • Demonstrated verbal and written skills in communicating scientific and technical information.

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.