Novavax
  • 26-May-2021 to 25-Jun-2021 (EST)
  • Engineering
  • 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 Manager/Sr. Manager, Quality Engineering to work in our Gaithersburg, MD Engineering group. This position reports directly to the Sr. Director of Engineering & Facilities and will work closely with all functions across the Novavax organization. The Quality Engineering Manager will directly manage a team of Quality Engineers and oversee the work of multiple manufacturing and GLP areas/value streams including product/process transfers, on-going commercial operations & continuous improvement, and new product/process/technology introduction/integration as required. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

Responsibilities include but are not limited to:

  • Manage day-to-day Quality engineering projects and activities, including scheduling and quality engineering staff allocations to projects.
  • Influence and collaborate with cross-functional team members on strategic program activities and ensuring seamless transition and implementation of new processes and new product commercialization activities (e.g., VIP/value engineering, product engineering, process engineering, advanced engineering, core competencies)
  • Responsible for the review, execution/investigation, and approval of NC's & CAPA, Validation's preparation and document review, Risk Management activities, and Quality System change control and document updates. Includes identifying opportunities and leading implementation of process improvements by utilizing Lean methodology and Six Sigma Tools. Will be expected to lead, own, and coach teams through complex/uncharted issues and subsequent solutions (e.g. design or process related CAPA).
  • Manage and/or oversee aspects of project activities with the accountability for successful completion of assigned deliverables related to the business objectives and Plant/Site project plans, schedule, and scope while applying engineering methods (e.g. Six Sigma & Lean methodology) to identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration and partnership with cross-functional groups.
  • Establish/improve operating policies and procedures that affect department, subordinate sections, and work units/manufacturing value streams. Define requirements for validation activities of various manufacturing processes, equipment, and utilities and investigate/address any deviations or failures accordingly. Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing, and implementing technology solution options.
  • Manage, mentor, and motivate assigned team of Quality Engineers to achieve their potential, while meeting project needs and business drivers. Develop a robust talent development plan in alignment with functional growth strategies of the department/Site. Responsible for the overall staff morale and culture for assigned areas and ensuring appropriate resources are allocated for on-going manufacturing operations, Plant/Site assigned projects, and product/process transfer activities (e.g. New Product Commercialization and Manufacturing Site Transfer).
  • Other incidental duties.

Minimum requirements:

  • Bachelor's Degree in Engineering or scientific field plus a minimum 10 years of relative experience required (or Master's Degree plus minimum 8 years of relative experience).
  • Progressive experience in management of technical and/or engineering disciplines Required.
  • Relative Quality Engineering, Quality Management, and/or Regulatory Compliance experience within regulated industry (Pharma, Biological Sciences, Medical Device/Therapies, etc.) required.

Additional preferred skills:

  • Proven successful project management leadership skills.
  • Proven expertise in both Microsoft Office Suite and related systems.
  • Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
  • Expert understanding of process and equipment validation requirements and strategies (IQ/OQ/PQ).
  • Expert in computer system Validation (CSV), and GAMP 5 standards.
  • Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines.
  • Comprehensive understanding of related aspects of quality engineering processes and/or systems.
  • Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards).
  • Expert knowledge of Six Sigma methodology and tools such as design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods, and Lean Manufacturing.
  • Knowledge of financial acumen as it relates to the business as well as quality engineering.
  • Demonstrates high Emotional Intelligence and acts as a Change Agent for the Site.
  • Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
  • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business.
  • Serve as core partner to Site Leadership Team.
  • Strict attention to detail and demonstrates sense of urgency.
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
  • Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.
  • Frequently interacts with subordinate production supervisors, engineers, operators, and/or functional peer group managers, normally involving matters between functional areas; often leads or par.
  • Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

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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