Novavax
  • 08-Sep-2017 to 07-Nov-2017 (EST)
  • Quality Control
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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 currently seeking a Quality Control Supervisor/Manager to join our talented Quality Control team in Gaithersburg, MD.  This role is responsible for supervising the day to day operations related to the Quality Control Biochemistry group. This is an exciting opportunity for the QC professional that is ready to advance their career.

 

Essential Duties and Responsibilities

Include, but are not limited to, the following:

  • Lead and direct the day to day operations of the QC Analytical Biochemistry group
  • Manage testing of critical reagents, in-process, release and stability samples
  • Review and compile laboratory test data and perform appropriate analyses
  • Ensure that data is reviewed and authorized in a timely manner
  • Ensure GMP compliance within the group
  • Lead laboratory investigations to determine root cause
  • Facilitate the maintenance of the lab including routine housekeeping, lab inventory, and equipment
  • Identify and troubleshoot equipment and software problems
  • Quickly identify and resolve gaps and provide guidance while troubleshooting complex problems
  • Professionally develop analysts to improve on individual and overall performance
  • Execute lab testing, if necessary
  • Ensure that suitable written records and work undertaken are kept in accordance with cGMP and company procedures
  • Assist with the writing, reviewing, and editing of standard operating procedures, laboratory protocols, and technical reports
  • Contribute to the management of deviation documentation, investigational reports, change control and CAPAs, which includes writing, reviewing and approving associated documentation
  • Investigate out-of-specification and recommend corrective actions
  • Participate in internal assessments and regulatory audits as required
  • Evaluate new biochemistry methods and equipment
  • Contribute to team building, training and problem-solving initiatives internally and cross site.
  • Communicate effectively with other relevant groups, including but not limited to Quality Assurance, Manufacturing, and Process Development
  • Other duties as assigned.

 

Requirements

Qualified candidates will possess the following:

  • Bachelor's degree in a scientific discipline. 2-8 years of supervisory experience
  • Minimum of 4 years' experience in a cGMP laboratory, preferably related to pharmaceutical industry operations
  • Detailed experience with HPLC, UV-Vis, and SDS-PAGE methodologies
  • Knowledge of FDA regulations regarding the manufacturing of biologicals
  • GXP (regulatory relevant skills and knowledge) GCLP/GCP/GMP
  • Ability to comprehend regulatory requirements and technical documentation and objectively make decisions
  • Track record of being a motivated self-starter
  • Excellent verbal and written communication skills
  • Exemplary multi-tasking and organizational skills
  • Working knowledge of LIMS preferred
  • Experience with Technology Transfer of analytical methods is a plus

 

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.

Novavax
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