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Senior/Lead Bioprocess Engineer - Downstream

Employer
Novavax
Location
Gaithersburg, MD
Closing date
Jul 7, 2022

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Industry
Engineering
Function
Engineer, QA Engineer, IT
Hours
Full Time
Career Level
Experienced (Non-Manager)
**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.** 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-MA$ cents A cents € zA' cents 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: We are seeking a Manufacturing Sciences and Technology Engineer with 5+ years of experience in downstream processing, preferably in an MS&T/Tech Ops type role. This person will be responsible for providing technical support and expertise to SARS-CoV-2 commercial Drug Substance sites, leading technical investigations, process improvement projects, and interpretation of manufacturing process data trends. Level is variable based on experience. Responsibilities include, but are not limited to: Work closely with DS sites to provide subject matter expertise on downstream processing, chromatography, and filtration topics Lead technical investigation teams to identify root causes of process and analytical deviations using sound problem solving methodology Perform statistical analyses of manufacturing process data, identification and investigation of adverse trends Assist with the writing and reviewing documents for INDs / regulatory section submissions Author and review CMC, Regulatory, and Quality documents such as risk assessments and E&L, technical memos and reports, microbial control, viral control, and process control strategy documents Minimum Requirements: PhD with 5+ years of relevant industrial experience or BS/MS with 8+ years of relevant industrial experience, in Biochemistry, Microbiology, Biology, Chemical Engineering, or closely related field. Knowledge of harvest technologies, chromatography, filtration, and viral removal/inactivation. Experience owning quality investigations such as deviations and out of specifications. Proven experience in collaborating in matrix teams in a technical environment Strong project and/or investigation management skills and adept at working collaboratively with cross functional teams. Strong interpersonal and communication skills. 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. #LI-SB #LI-remote Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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)

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