BioProcess Engineer/Scientist Manufacturing Sciences and Technology (MS&T)

Employer
Novavax
Location
Rockville, MD
Posted
Jul 17, 2017
Closes
Aug 07, 2017
Function
Engineer
Hours
Full Time
Are you ready to work for one of Washington's Top Workplaces? At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life. We are seeking an Engineer/ Scientist with a strong technical background to join our Manufacturing Sciences and Technology (MS&T) team in Gaithersburg, MD. This position will have a wide range of responsibilities to support GMP manufacturing. Responsibilities include but are not limited to: Lead tech transfers from Process Development team to internal Manufacturing team or to external CMOs. Evaluate facility fit, author necessary documentation, and assist with campaign readiness preparation and project planning. Partner with Validation, Engineering, and Automation teams for capital projects, including drafting of specifications, install, commissioning, and qualification of new equipment.Serve as manufacturing technical support for equipment and process validation activities. Lead comprehensive, cross functional investigations to resolve issues that may be due to process robustness, equipment failure, inadequate documentation, material issues, personnel errors, or other causes.Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.Coordinate cross-functionally with the Process Development group to drive next generation process development to address manufacturing pain points. Evaluate new technology, software, and equipment for Clinical and Commercial Manufacturing use. Utilize Project Management skills to lead changes/updates to manufacturing processes through change controls, working with Manufacturing, Engineering, and Validation to implement those changes.Propose and/or revise raw material specifications and evaluate vendor change notifications for impact to Manufacturing. Minimum Requirements: PhD, MS or BS in relevant engineering or scientific discipline with 2-5 years experienceKnowledge and hands on experience with large scale biopharmaceutical processing Ability to influence cross-functionally in a matrix environment.Strong oral and written communication skills. Experience authoring GMP change controls, technical reports, and/or specifications. Experience with process monitoring, manufacturing data acquisition, data analysis tools, and statistical analysis in JMP or Minitab. Preferred Qualifications: Demonstrated ability in Project ManagementA full understanding of current good manufacturing practices (cGMPs)Experience and successful application of Operational Excellence tools/methodologies with demonstrated business resultsPrevious experience in automated production control systemsKnowledgeable of FDA regulations regarding the manufacture of biological including regulatory inspection experience. Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan. We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. Job Posted by ApplicantPro