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Scientist V

Ft Worth, TX 76134

Posted: 09/20/2023 Employment Type: Contract Job Category: Scientific Job Number: 576445 Is job remote?: No Country: United States

Job Description


Seeking to hire a Principal Scientist to join our R&D Team in Fort Worth, TX. You will be responsible for toxicological and biocompatibility evaluations of products and technologies required for product approvals and patient safety across the Technology Platforms.

Responsibilities:
  • Partner with toxicology leaders to develop robust biocompatibility and nonclinical testing strategies to meet project goals and ensure patient safety of products.
  • Conduct safety assessment for new product development and provide solutions for evaluation of safety risk for manufacturing and product life cycle assessments.
  • Work functional leaders across the organization to execute product design evaluations required for product approvals
  • Drive interactions with project teams early in the process to identify potential toxicological/safety risks to projects and develop robust Biological Evaluation Plans to mitigate the risks.
  • Interface closely with the manufacturing site to ensure business needs are met for life cycle management and materials teams for product stewardship toxicology assessments.
  • Competent in literature searches, extracting relevant information, critical study selection to aid in developing the risk assessment.
  • Familiar or experience in conducting risk assessments according to ISO 10993-17.
  • Experience with in-silico and QSAR models for use in toxicological risk assessments (e.g., Derek/Nexus, Tox Tree, OECD QSAR Tool Box, etc.).
  • Familiar or experience with ISO 14971, ISO 13485, ISO 10993-1 standards.
  • Experience developing and executing nonclinical toxicology studies under Title 21 CFR; Part 58 Good Laboratory Practice (GLP) Regulations.
  • Familiar or experience with medical device submissions (e.g., PMA, IDE, MDR, etc.) to regulatory authorities.

Key Requirements/Minimum Requirements
  • Bachelors Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
  • The ability to fluently read, write, understand and communicate in English
  • 5 Years of Relevant Experience
  • Work hours: Standard M-F
  • Travel Requirements: Minimal
  • Relocation assistance: No
  • Sponsorship available: No

Preferred Requirements:
  • Advanced Degree and five years of directly related experience
Target pay: $60/hr

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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