Principal Scientist, Quality Control (Analytical Technical Support)

Published
January 11, 2019
Location
Gaithersburg, MD
Category
Default  
Job Type

Description

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 have an exciting opportunity for a Principal Scientist in the Quality Control Analytical Technical Support team in Gaithersburg, MD. The successful candidate will need a strong analytical and compliance background with proven leadership skills that will help establish the Analytical Technical Support team as the scientific experts for a growing Quality Control Department. This position will support Quality Control through involvement with complex analytical and/or manufacturing investigations, method troubleshooting, method validation/transfer, and authoring of CMC analytical sections in support of regulatory filings/responses. This position will report to the Head of Quality Control.

 

Responsibilities include but are not limited to:

  • Responsible for the QC analytical lifecycle management program post method qualification
  • Responsible for the oversight and management of the method transfer and assay validation programs.
  • Authors transfer/validation protocols and reports
  • Collaborates with Analytical Development regarding the introduction of new analytical technologies and instrumentation
  • Troubleshoots and investigates trends in performance of analytical methods used for release/stability and in-process assays
  • Provides analytical technical expertise for manufacturing deviations and OOS/OOT investigations by working in concert with Manufacturing and Quality Assurance
  • Serves as the technical liaison between Quality Control and Analytical Development
  • Represents QC on cross-functional teams focused on solving complex product and/or analytical issues
  • Responsible for the oversight and management of the method transfer and assay validation programs.
  • Authors transfer/validation protocols and reports
  • Authors deviations and investigations
  • Collaborates with Analytical Development in the execution of method transfers and validations
  • Works in collaboration with Analytical Development to identify improvements in the analytics that improve overall efficiency in QC Operations
  • Works in collaboration with development and manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CMOs.
  • Delivers analytical source documentation for CMC sections of IND/BLA filings and addresses technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications
  • Builds and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC, Quality as well as alliance partner counterparts, as applicable.
  • Manages 1-2 scientific staff

 

Minimum Qualifications:

  • Ph.D. in Biochemistry, Chemistry, or related scientific discipline with at least 5 years of experience in the biopharmaceutical industry
  • Demonstrated scientific knowledge and experience in analytical methodologies used for Large Molecules
  • Demonstrated broad knowledge and experience in method transfers and validations
  • Established knowledge of applicable global drug development and regulatory standards and current expectations
  • Established knowledge and application of cGMPs/GLPs, ICH, FDA CMC Guidance Documents
  • Experience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters
  • Strong analytical and strategic thinking
  • Demonstrated problem-solving capabilities and cross-functional understanding
  • Excellent communication skills (oral, written, presentation)

 

Preferred Qualifications:

  • Experience and successful application of OE tools/methodologies with demonstrated business results
  • Experience in project management
  • Experience with the use of statistical software and approaches for experimental design and troubleshooting
  • Experience in leadership of scientific staff

 

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.

Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

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.

 

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/974650-222192

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