Novavax
  • 22-Aug-2017 to 21-Oct-2017 (EST)
  • Quality Control
  • Gaithersburg, MD, USA
  • Full Time - Non-Exempt

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 Analytical Development Stability Specialist to be responsible for day-to-day operations related to Analytical Development's stability and retain program.  The candidate must possess excellent time management skills, ability to manage multiple projects, and a proven history of working successfully in a team environment.

 

Responsibilities include but are not limited to:

  • Performs GMP release and stability testing in Quality Control
  • Performs day to day activities for cell propagation used for QC assays.
  • Assist in assay troubleshooting
  • Receives, distributes, tracks and coordinates cGMP samples for testing
  • Prepares buffers and reagents
  • Reviews test records, laboratory notebooks, protocols and reports
  • Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
  • Participates actively in technology transfer, method qualification and validation
  • Gather and analyzes data for final disposition using preapproved documentation
  • Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate
  • Logs and maintains all references and standards used for testing
  • Assists in the writing, reviewing and editing of standard operating procedures
  • Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses
  • Performs root cause investigation and analysis
  • Participates in continuous improvement projects
  • Assist in the maintenance of the lab including routine housekeeping activities
  • Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
  • Other duties as assigned

 

 Minimum requirements:

  • Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline
  • Minimum 5 years of related experience working in a biological quality control laboratory environment
  • Knowledge and expertise in principles and practices of current Good Manufacturing Practices (GMPs)
  • Excellent analytical skills and knowledge
  • Strong troubleshooting skills for equipment and software
  • Solid ability to work independently (minimum supervision) & as part of a team
  • Experience in Assay Qualification and Validation
  • Knowledgeable in FDA regulations regarding the manufacturing of biologicals.
  • Good aseptic technique is essential
  • Ability to work in fast paced environment
  • Possesses excellent organizational, time management and multi-tasking skills in order to meet deadlines
  • Excellent problem solving methodology, using industry accepted concepts and tools to solve problems in creative and effective way
  • Excellent communication/interpersonal and presentation skills
  • Proficient in Windows based software to include Excel and Word
  • Experience writing & reviewing technical documentation(qualification and validation protocols and reports), is a plus
  • Possesses a strong scientific and technical background, sufficient to establish credibility with team and other departments
  • Strong attention to detail
  • Experienced with EHS guidelines in a laboratory environment

 

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Our product pipeline targets a variety of infectious diseases with vaccine candidates currently in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus (EBOV). Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden and employs over 300 individuals 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.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

Novavax
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