If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.
Individually, we’re skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company committed to helping address serious infectious diseases globally through the discovery, development, and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research has tremendous potential to make a substantial contribution to public health worldwide.
The Quality Control Senior Analyst is responsible for day-to-day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls, and CAPAs as part of typical QC operations.
Responsibilities include but are not limited to:
- Perform GMP release and stability testing in Quality Control.
- Write technical reports and supporting documentation such as deviations, reports, testing protocols, and trend analyses.
- Review laboratory notebooks, protocols, and reports.
- Perform day-to-day activities for cell propagation used for QC release and stability assays.
- Participate in technology transfer, method qualification, and validation.
- Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
- Participate in internal assessments and regulatory audits as required.
- Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures.
- Lead the lab in 5S and 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:
- Minimum of a Bachelor's degree or equivalent in a scientific discipline.
- Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations.
- Hands-on experience performing ELISA in a cGMP environment.
- Hands-on experience performing SDS-PAGE in a cGMP environment.
- Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay.
- GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required.
- Excellent analytical skills and knowledge.
- Strong troubleshooting skills for equipment and software.
- Solid ability to work independently (minimum supervision).
- Ability to lead others, as needed.
- Ability to effectively collaborate with others.
- Excellent communication skills and be conversant in computer systems.
- Excellent multi-tasking and organizational skills.
- Excels in time management.
- Strong attention to detail.
- Good understanding of relevant regulatory/industry standards and requirements.
The annual base salary (or hourly wage) for this position falls within the range of $78,250.00-$101,750.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience.
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, and a 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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