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Risk Assessment Specialist

Risk Assessment Specialist

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA.  Our mission is to provide quality pre-clinical research services to Medical Device, Pharmaceutical, and Biotech industries. 

This position is at a successful, preclinical research organization with highly diversified capabilities based in the Greater Boston area.  It is ISO/IEC 17025 accredited and registered with the US FDA and Japanese MHLW for both drug and medical device testing.  The Company performs in vivo, analytical, and in vitro testing for the pharmaceutical, biotechnology, and medical device sectors. Services include toxicology (acute, sub chronic, and chronic toxicity, reproductive toxicity, genetic toxicology, and carcinogenicity), pharmacokinetics, toxic kinetics, bioavailability, ADME, chemical characterization, impurities analysis and synthesis, bioanalytical, and microbiology.  The company has over 1,000 clients in 51 countries worldwide.  Toxikon has a distinct advantage in the industry due to its unusual capabilities to provide a wide range of services that can be customized to the Sponsor Requirements.

The position is in Toxicological Risk Assessment (TRA), which report to the Director of ToxSmart, Toxikon’s Consulting Group.  This is a unique opportunity to play a key role in a dynamic and thriving group. You will enjoy the enormous visibility and entrepreneurial freedom that comes with working in a tight and highly-energized team. Exposure to diverse therapeutic and medical device areas adds to the excitement of working in this dynamic business. 

Candidate will be responsible for all aspects of TRA as per ISO 10993-17 and ICH M7 guidelines, which will include literature-based research and review, exposure modeling, complex data review, investigation of medical device manufacturing practice and usage, and the preparation of technical summaries and reports.  Therefore, a background in toxicology, or other life science is likely required. The work is tied to the chemical characterization of a test article and the Extractable/Leachable (E/L) analysis performed as per ISO 10993-18, therefore, a background in chemistry would be a plus. Other responsibilities include providing technical and administrative support in a manner that is respectful of client deadlines. Successful candidate will be a good communicator, with proficient writing skills, and will be able to work autonomously at times, on self-contained projects. He or she will be expected to be organized, detail-oriented, and adept at prioritizing work.   

Requirements: 

Experience 

Experience in risk assessment or in analytical or  biological testing is desired, with a working knowledge of TRA.  

 Education, credentials 

  •  BS with experience in risk assessment or toxicology, or Masters degree in a life science required.

Skills 

  • Excellent technical, written, and communication skills 
  • Strong organization and administrative skills 
  • Strong problem-solving and analytical skills    
  • Willingness to adapt to rapidly changing scientific and regulatory environments 
  • Supporting sales and all business development processes 
  • Proficient with databases and Microsoft applications  

 Attitude 

  • High energy and entrepreneurial 
  • Enjoys working in a “roll-up your sleeves” environment  

 Compensation and Benefits 

  • Compensation commensurate with experience  


This position is located in Bedford, MA. 

For additional information about Toxikon go to www.toxikon.com. 

 Toxikon offers a comprehensive benefits program including: paid vacation sick time, 401(k) plan with company match, medical, dental, vision, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state, and local laws. 

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