Toxicologist

2 weeks ago
Company
Noblis ESI
Requisition #
5797
Security Clearance
Secret
FT/PT/On-Call
Full Time
Job Category
Bioinformatics

Responsibilities

From policy and pathogens to prototypes and preparedness, Noblis is maximizing the success of our nation’s chemical, biological, radiological, and nuclear (CRBN) medical defense mission.  We are working with industry, academia, international, and intra-government partners to develop new processes, policies, tools, and technologies that will strengthen our national response to CBRN incidents and protect our Warfighters.

 

In this role, the Toxicologist’s role will include:

 

  • Serve as the technical interface between non-clinical stakeholders and candidates in order to establish studies designs and achieve regulatory quality standards.
  • Hold a leadership role, problem-solving technical issues related to non-clinical studies and communicating solutions and emerging risks, accurately and timely, to the Vaccine Manager, Deputy JPM, and other staff members.
  • Work with IPTs comprised of civilians, military and non-Government personnel, and matrix support staff with diverse areas of expertise (i.e., PMs, budget analysts, regulatory specialists, acquisition analysts, and logisticians).
  • Partner with diverse product development teams, to include Government personnel and other performers (e.g., statisticians, veterinary anatomic pathologists, veterinary clinical pathologists, toxicologists, clinicians, pharmacologists, formulation scientists, etc.).
  • Represent the organization, communicating with individuals both in and outside the organization, to include customers, the public, and other Government agencies and external sources.
  • Derive interpretations from data and design subsequent experiments with minimal oversight in support of non-clinical testing of vaccines under the Animal Rule.
  • Review all aspects of testing and data analysis in order to generate detailed and well-documented recommendations to be provided as guidance for a path forward.
  • Contribute critical scientific and regulatory elements for high-quality nonclinical study protocols, to include:
    • Early review of proposals for advising PMs and external performers of expectations in the forthcoming study protocol content
    • Ensuring that relevant, Industry-standard scientific practices are included to prevent both a) critical data gaps at the time of interpretation and b) excess, unnecessary efforts that do not serve the furtherance of study objective(s)
    • Ensuring that the study protocol uses correct scientific and regulatory designations, terminology, and section formatting to serve as the framework to the report
  • Conduct draft report reviews of non-clinical studies based on exhaustive data review to ensure:
    • Technical and scientific data integrity
    • Correct or defensible written interpretation of data (as indicated)
    • Reporting limited to the scope of data within the study
    • Appropriate written explanatory is provided for each data set
    • Adherence to compliance with appropriate regulatory standards
  • The candidate will provide consultation to clients in the design of experimental studies and protocols, interpretation of experimental results, review of study reports, and recommendations from other performer(s).
  • Interpret the meaning of information for others, to include:
    • Translating or explaining what the information means and how it can be used
    • Generating, interpreting, and communicating results from in vivo nonclinical studies to teams including other advanced development scientists, PMs, and non-scientists)
  • Review other performers’ implementation of activities to ensure they are in compliance with Good Laboratory Practice, standard operating procedures, protocols, and regulations related to ethics and animal welfare.
    • Ensure that experimental data are being properly collected
    • Participate in performer site visits and/or on-site audits as needed
  • Maintain current technical knowledge and skills, applying them to the job as necessary.
  • Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person.
  • Work independently and as part of a team.
  • Ensure appropriate subject matter experts are involved in the day-to-day management of non-clinical studies (e.g., biostatistician, toxicologist, biologists, clinicians, pharmacologists, etc.).
  • Participate in source selection panels as a subject matter expert in reviewing relevant sections of submitted proposals of vaccine development.
  • Work independently and as part of a team.

Qualifications

Education and Experience Required:

  • The ideal candidates would possess a PhD in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience OR a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience. 
  • It is preferred that the candidate is a board-certified toxicologist.  
  • Possess strong technical training in non-clinical studies to support candidate vaccines in preclinical studies 
  • Possess five (5) years of experience designing and conducting candidate vaccines in non-clinical studies, both large and small animal models, for an IND.  
  • Possess the ability to independently design and execute non-clinical studies. Experience with development of non-clinical efficacy studies to support licensure under the Animal Rule is preferred.  
  • Possess experience working as a GLP regulatory toxicologist and an understanding of regulatory guidelines (i.e., FDA GLP and/or GMP) and regulatory/quality compliance requirements. Experience in a regulated laboratory environment is preferred.  
  • Strong critical thinking, analytical, and problem solving skills, as well as good organization skills to balance and prioritize work.  
  • Strong interpersonal and communication skills, both oral and written

 

LI: 10 - #LI-JO1

Overview

Noblis and our wholly owned subsidiaries, Noblis ESI and Noblis NSP, are solving difficult problems that help our government and our country. We bring the best of scientific thought, management, and engineering expertise with a reputation for independence and objectivity. We support a wide range of government and industry clients in the areas of national security, intelligence, transportation, healthcare, environmental sustainability, and enterprise engineering. Learn more at noblis.org/about.

 

Why work at a Noblis company?

Our employees find greater meaning in their work and balance the other things in life that matter to them. Our people are our greatest asset. They are exceptionally skilled, knowledgeable, team-oriented, and mission-driven individuals who want to do work that matters and benefits the public.

 

Throughout our history, we have continually earned numerous workplace awards.  More recently, we have been recognized as a Top Workplace by The Washington Post for 4 consecutive years (2017, 2016, 2015, 2014), one of the Best Medium-Sized Places to Work by Glassdoor's Employee Choice Awards, and one of the World's Most Ethical Companies by the Ethisphere Institute. 

 

Noblis maintains a drug-free workplace and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race.

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