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Sr. Scientist, Analytical Development (Characterization)

Employer
Novavax
Location
Gaithersburg, Maryland, United States
Salary
Competitive
Start date
21 Sep 2022
Closing date
21 Oct 2022

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Discipline
Manufacturing, Process
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 :

We are seeking a Sr. Scientist to join our Analytical Development department to lead a group of energetic scientists. The qualified individual should have demonstrated proficiency with characterization, development and applications for Immunoassays, Protein Biochemistry and LC/MS involving HPLC, Size Separation based methods, Western Blot, qPCR, SDS-PAGE w/ Densitometry, ELISA, TEM, Octet (BLI), size-exclusion chromatography (SEC) for phase-appropriate characterization of protein or vaccine products. Additionally, having knowledge with residual assays via HPLC-UV or HPLC-FLD and intact mass determination via LC/MS-TOF analysis is a plus. The candidate will take a leading role in characterizing and compiling data from various methods to better understand the process comparability within a site and among various sites for testing vaccine products. The candidate will be expected to work efficiently with cross-functional teams. Good understanding FDA and ICH guidelines and practical knowledge with assay validation is a plus for this position.

This person will report to the Director (Characterization) of Analytical Development.

Responsibilities include but not limited to :
  • Lead and build a team of professionals towards reviewing, discussing and compiling data provided from test methods as a tool for comparability assessment and characterization of recombinant protein vaccine products
  • Participate in cross-functional workflows and provide scientific guidance to teams
  • Apply new cutting-edge technologies to evaluate throughput for in-process testing and enhance capability of product characterization
  • Thoroughly analyze results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations for analytics
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Write, edit, and review analytical sections of CMC regulatory filings
  • Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology
  • Present scientific findings at internal and external meetings
  • Assigns work and provides guidance to subordinates to achieve goals in accordance with established policies

Minimal Requirements :
  • MS or PhD in analytical science, chemistry, biochemistry, or related field with minimum of 8 years of experience in biopharmaceutical and/or vaccine development.
  • Informal management/team lead experience
  • Ability to manage a team of scientists, and develop and motivate scientists to achieve results
  • Demonstrated leadership skills and capable of working collaboratively and cross functionally.
  • Ability to critically analyze data using statistical tools and to compile and review technical reports.
  • Ability to define priorities and process to get things done.
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) is preferred.
  • Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
  • Good understanding of statistical tools and knowledge of DOE and QbD principles is preferred
  • Strong communication, presentation, and writing 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.

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.

#LI-SB

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)

Company

Find out more about working for our company

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Brief Company Description; 

We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world.

Our mission

We never rest in our quest to protect the health of people everywhere.

Novavax is here to make a difference. We’re a biotech company focused solely on developing life-saving vaccines to fight infectious diseases.

What sets us apart? Solid science tested by decades of research. Vaccines developed from trusted technology that are both safe and efficacious.

And a global network that will help ensure our vaccines reach everyone who needs them.

Company info
Website
Mini-site
Novavax
Location
21 Firstfield Rd
Gaithersburg
MD
20878
United States

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