Novavax
  • 20-May-2021 to 21-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 Manufacturing Associate IV 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:

  • Cell amplification of suspension-based insect cells through shaker flasks, bioreactors, and disposable bioreactors.
  • Infection and harvest processes using continuous centrifugation and depth filtration.
  • Purification steps using flow-through and column capture chromatography.
  • Drug substance formulation.
  • In-house buffer preparation and support activities.

Minimum requirements:

  • Bachelor's degree (engineering or biological science is preferred) with 4+ years of industry experience, Associate degree with 5+ years of industry experience, or No degree with 6+ years of industry experience.
  • Experience with RCA and investigations
  • Experience with technical writing
  • Demonstrate interpersonal, technical aptitude, and problem-solving skills.
  • Knowledge in principles and practice of current Good Manufacturing Practices (cGMPs) from development or commercial applications.
  • Effectively contribute to a team environment with safety at the forefront.
  • Flexible availability including weekends and holidays.
  • Experience with multi-tasking and organizational skills.
  • Show proficiency in 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.

Production performance:

  • Coordinating and leading Tier 1 huddles
  • Building and delegating hourly schedule for manufacturing; defining length of operation and personnel responsible.
  • Assist with daily work assignment schedules and coordinating manufacturing activities.
  • Accountable for daily adherence to production schedule and deviation avoidance across upstream and downstream process suites.
  • Organize and lead onboarding initiatives for new manufacturing staff including partnering with experienced operators.
  • Coordinating training of staff
  • Leading by example in maintaining a positive, safe, and compliant work environment through reinforcement of policies and procedures related to health, safety, and Good Manufacturing Practices.
  • Understands how manufacturing supports business goals.
  • Operates with minimal guidance from management on scope and expectation of work.
  • Provides higher level decision making in the GMP area regarding safety, quality, and cost.

Technical operations:

  • Leads projects that interface with different manufacturing teams.
  • Works with Technology Transfer groups to implement process changes and improvements.
  • Assists with real-time investigation and triage of process and equipment deviations.
  • Fosters an environment of process ownership and real-time monitoring of process performance.
  • Identifies challenges in the current manufacturing processes and identifies ways to create more robust processes
  • Serves as manufacturing liaison on broad Novavax or external projects.
  • Partners with Operational Excellence team to learn, sponsor, and incorporate continuous improvement techniques.
  • Assists with technical group discussions.
  • Effectively communicate manufacturing position on topics to other departments, peers, and managers
  • Present results of work, interpret data, and draw informed conclusions.
  • Diagnose and troubleshoot complex problems.

Compliance:

  • Maintain work area in state of inspection readiness.
  • Reviews safety investigations.
  • Capable of participating in internal and external audits and inspections.
  • Identifies quality-related trends and facilitates implementation of corrective actions.
  • Effective at root cause analysis, investigations, deviations, change controls, and implementing sustainable functional CAPAs.

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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