Bioprocess Engineer II (Contractor) Remote

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™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Summary of the Position :

Novavax is seeking a BioProcess Engineer II (Contractor) to provide technical oversight of quality system and regulatory documentation across contract manufacturing sites. The successful candidate will serve across various functions within the MS&T department and serve as a primary point of contact between internal and external stakeholders to ensure development of quality systems and other CMC documentation in a manner that is harmonized across sites and defendable to global health authorities. The candidate must have a strong understanding of process science, process control strategy and regulatory compliance requirements while establishing close relationships with personnel across multiple disciplines/departments throughout the company.

This person will report to the Sr. Manager, CMC Documentation and Strategy

Responsibilities include, but are not limited to :

Develop, oversee, lead:

• Manage CAPAs, Change Controls and Deviations originating from and being implemented to CMO sites
• Author internal quality systems, risk assessments, control strategy documents, regulatory filings, and other CMC documentation
• Effectively convey information to internal and external customers
• Track metrics across manufacturing sites to identify trends and opportunities for improvement
• Meet with key Novavax stakeholders to gain alignment on CMC strategy
• Facilitate risk assessments and other cross-functional meetings and teams
• Work closely with project managers at both Novavax and CMOs to ensure project milestones are maintained
• Other duties may be assigned as needed

Minimum Requirements :

• BS in relevant scientific discipline (Biochemistry, Microbiology, Biology, Chemical Engineering or closely related field) with 3 years of relevant industry experience
• Strong understanding of process science, process control strategy and regulatory compliance requirements
• Experience in change management and non-conformance resolution
• Strong project management skills and adept at working collaboratively with cross functional teams
• Strong technical writing and interpersonal communication skills
• Experience with vaccines or infectious disease a plus
• Experience in inspection/audit observation response
• Continuously seek to improve processes for improved performance
• Experience working on cross-functional teams
• Proven ability to run multiple tasks concurrently under aggressive timelines in a dynamic environment
• Comfortable with uncertainty and high expectations

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, 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.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

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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)