Toxicologist

POSTED: July 16, 2019
BUSINESS: Cook Biotech, Inc.
POSITION TYPE: Full-time
START DATE: Immediate Availability

Responsibilities:

  • Conduct toxicological and biocompatibility assessment of new product design, design changes, manufacturing process and post-production life-cycle activities.
  • Act as the subject matter expert (SME) for the design and execution of toxicological and biocompatibility testing. Advise Engineering on data requirements and biocompatibility and toxicological risk control strategies.
  • Author Toxicological and Biological risk assessments for regulatory compliance.
  • Provide advise on testing strategy and test design.
  • Work with Regulatory Affairs to answer feedback from regulatory agencies on issue relating to biological safety.
  • Prepare and present technical presentations to key stake holders.
  • Maintain and evolve quality system documentation and procedures relevant to toxicological and biological risk assessment.
  • Train staff on new procedures/documents.
  • Maintain strong relationship with external test labs.
  • Remain current and apply the understanding of ISO 10993, ISO 14971 and regulatory agency guidance documents (e.g. FDA, PMDA etc.) and CBI quality system requirements.

Skills:

  • Ability to manage multiple projects in cross functional teams.
  • Strong written and verbal communication skills of technical subject matter.
  • Understanding of analytical chemistry methods. Knowledge of animal testing is a plus.
  • Laboratory experience in analytical chemistry and/or in vitro or in vivo

Qualifications:

  • PhD degree in Toxicology OR relevant experience combined with internationally recognized certification in toxicology.
  • Experience from medical device or pharmaceutical industry is a plus.
  • Knowledge of ISO 10993 and interpretation in domestic and international regulatory settings is a plus.
  • Must have good knowledge to use available toxicological software or database to analyze and interpret test results.

APPLICATION INSTRUCTIONS:

Interested candidates please send cover letter and resume to bahnert@cookbiotech.com

 

  • Job Listings

Kurz Purdue Technology Center, 1281 Win Hentschel Blvd., West Lafayette, IN 47906, 765-588-3470

© 2016-17 Purdue Research Foundation | Maintained by Purdue Research Foundation

Trouble with this page? Please contact Purdue Research Foundation by Phone, 765-588-3470, or FAX, 765-463-3501.