Job Description

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M(TM) adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Summary of the Position :

This position is to support NOVAVAX' Quality Assurance program for Vaccine Drug Substance Manufacturing operations. The PIP is Responsible for onsite QA oversight of CMO Drug Product manufacturing activities. The PIP is the key point of contact with the CMO Quality lead and responsible to drive Novavax team to meet timeline for deliverables-batch review, quality records and batch disposition duties. This is position is based in South Korea to act as the Person in Plant at our CMO.

Responsibilities include, but not limited to :

• Establish collaborative working relationship with CMOs to ensure compliance to regulations and that product quality is ensured.
• Ensures adequate process, analytical and documentation transfer by observing the operations at the CMO
• Compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs).
• Strengthen tech transfer and manufacturing process by providing a dedicated Quality resource who is on site partnered with Novavax Manufacturing PIP in the tech transfer team.
• QA input for issue investigation/remediation and escalation of site level issues to QA Point of Contact and ensure execute according to the Quality agreement.
• Work with Pharmaceutical Operations and CMO as the Quality Contact to resolve/escalate Quality issues during production, testing, warehousing and distribution.
• Allow for real time QA input/assessment of all non-conforming incident-deviations, OOS,
• Oversee timely reporting and closure of Quality events- changes, deviations, OOS, complaints
• Oversight of change management
• Ensure adequacy/completeness of batch record documentation and deviations/comments are documented and are ready for release in a timely manner.
• Review and input for generation of new or revised master batch records, SOPs and other controlled documentation. Author quality documents as assigned.
• Review and prepare batch disposition, shipment documentation
• Perform batch release of drug substance, cell banks as required. This to include coordination of QP certification of drug substance and drug product as defined in Quality/Technical Agreements.
• Responsible for proactive monitoring the performance of CMOs/ CTL's & suppliers to ensure that they remain in a state of control are aligned to metrics/ expectations, and leading the effort to drive improvement
• Responsible for the development & assessment of quality metrics, KPIs and reports associated with CMO's / CTL's and to recommend actions as a result of such reviews / reports.
• Represent QA CMO/ CTL management team with cross functional project team
• Responsible to ensure appropriate escalation, communication channels are used ensuring that Senior management are kept informed of critical issues.
• Support internal and regulatory agency inspections at CMO. Responsible to work with CMO compliance lead to ensure CMO's/ CTL's are inspection ready.
• Responsible for hosting meetings with external parties and representing Novavax in a professional manner.

Minimum requirements :

• BS./B.A. biological sciences, physical sciences
• Minimum 10 years of combined experience in the biopharmaceutical/pharmaceutical industry, with at least 5 years working in process and manufacturing GMP environment.
• Strong technical knowledge and hands on experience with manufacturing and process validation concepts and procedures in a GMP environment.
• Experience working with Biopharmaceuticals (CBER, FDA, EMA, MHRA) in a fast-paced environment.
• Prior experience conducting process transfers, scale up and validations.
• Working knowledge of CMO operations with respect to IMP/CTM manufacturing and process transfers.
• Knowledge of Global GMP regulations and guidelines.
• Strong organizational skills and ability to manage multiple tasks at one time.
• Strong communication skills, (both written and oral), facilitation and presentation skills.
• Experience with Pre-Fill Syringes and drug substances manufacturing
• Position location: South Korea
• PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Every day our employees impact the future of health by preventing disease. To recognize their contributions, we offer them performance-based pay; a flexible, welcoming work environment; comprehensive and competitive benefits.

Novavax is headquartered in Gaithersburg, Maryland. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals 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 protected characteristic.

#LI-DC

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)