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Senior Scientist, Formulation Development

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

View more

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

Job Details

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 :

We are seeking Senior Scientist to support the Formulation Development department. The qualified individual will be responsible for the design, execution, and management of scientific studies in the development of both liquid and /or lyophilized drug product formulation to support product development from initial candidate identification through commercialization. The individual will also bring solid knowledge of biophysical characterization of formulations as well as development of bioanalytical tools for predictive stability of protein nanoparticles. The position is to provide scientific expertise and leadership in all formulation physicochemical characterizations and drug product formulation development studies. The candidate will be expected to take an active role in the professional development of direct reports. The position will be located at our Gaithersburg, MD facility and report to the Director of Formulation Development.

Responsibilities include but are not limited to :
  • Design, definition, and execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations. Scientific Activities including, but not limited to:
  • Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development experimentation.
  • Assay method development and validation including: AUC, CD, Fluorescence spectroscopy, DSC, ITC, UV/Vis spectroscopy, FTIR, SLS and HPLC.
  • Develop activities to evaluate formulations, processes, and equipment.
  • Development of adjuvanted and unadjuvanted formulations of protein nanoparticle vaccines.
  • Design lyophilization cycle studies for drug product manufacturing.
  • Develop SOP documentation for new processes and equipment.

Percentage of time (Approx.): 45%
  • Participate in all scientific development and scale-up activities of drug product processes from bench top to pilot scale and technology transfers. Activities including, but not limited to:
  • Review all formulation developed methods and protocols.
  • Discovery and selection of techniques to solve current formulation issues.
  • Participation in cross-functional product development team to provide scientific expertise.
  • Collaboration with other departments to identify equipment, conduct scale-up studies, and support existing products.
  • Participate in Process Development activities.
  • Support development of new technologies and enhanced technology capabilities applicable to formulation development and commercialization.
  • Support in activities and documentation for technology transfer to CMC facilities.

Percentage of time (Approx.): 30%
  • Lead scientific discussion and investigations for all drug substances and drug products being developed. Percentage of time (Approx.): 5%
  • Provide expert guidance to formulate small and large scale lots of liquid, frozen or lyophilized plasma protein drug candidates. Percentage of time (Approx.): 5%
  • Authorship of formulation protocols, SOP, batch records, and development reports. Percentage of time (Approx.): 5%
  • Project management of research associates in support of the larger drug development project. Percentage of time (Approx.): 4%
  • Review both the data generated in the formulation development studies and their resulting reports. Percentage of time (Approx.): 2%
  • Review and evaluate developed lyophilization cycle processes to manufacture freeze-dried drug products. Percentage of time (Approx.): 1%
  • Presentation of scientific findings internally and publicly. Percentage of time (Approx.): 1%
  • Consistently generate innovative and unique solutions to formulation market needs and submit idea disclosures. Percentage of time (Approx.): 1%
  • Support Regulatory Affairs in IND and BLA submission. Percentage of time (Approx.): 1%

  • Minimum Requirements :
    • Requires PhD in relevant field with 5 years relevant experience or a minimum of 10 years relevant experience with a Masters degree.
    • Direct experience in leading direct reports in scientific projects
    • Experience in formulation product development, Quality by Design (QbD), Design of Experiment (DOE) processes.
    • Direct experience and expertise in protein drug substance synthesis, characterization, evaluations and formulation development.
    • Direct experience and expertise in biologics, and/or vaccine drug product development
    • Direct experience and expertise in lyophilization cycle design, operations, and evaluation for freeze-drying drug products.
    • Direct experience in project leadership and grant management.
    • Significant experience in designing and initiating research projects.
    • Knowledge of aseptic manufacturing and fill/finish process related to liquid and solid formulation products.
    • Knowledge and experience in GLP and GMP requirements.
    • Demonstrated expertise with bio/analytical and physicochemical characterizations of proteins, including protein synthesis, structure, stability, aggregation, and solubility is highly desirable.
    • Ability to work independently with strong problem-solving skills.
    • Ability to lead scientific group discussions and capture and execute action items concluded from said groups.
    • Strong technical writing skilled supported by scientific publication history.
    • Other duties as assigned

    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-JB

    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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