Toxicologist

JOB DESCRIPTION

Job Title

Associate Toxicologist

Job Description

The Associate Toxicologist will play an important role in generating Toxicological Risk Assessments for Philips Sleep & Respiratory care devices / products, ensuring they are safe for use by the intended patient population.

Your role :

• Designs, develops, evaluates, and conducts toxicological assessments of products with focus on ISO 10993 and ISO 18562 aspects and concludes this with formal reporting.
• Support toxicological assessments for consent decree activities, EU MDR Compliance, and DHF remediation.
• Preparation of toxicological risk assessments and dossiers using Organization for Economic Co-operation and Development (OECD), European Chemicals Agency (ECHA) and Restriction of Chemicals (REACH) guidance and any other regulatory agencies databases.
• Support the design, monitoring, and interpretation of In Vitro, In Vivo, or pre-clinical bio-compatibility studies conducted under Good Laboratory Practices (GLP).
• Interpreting the results of Biological / Volatile Organic Compound tests for impacts to patient safety and preparation of expert reports on toxicology / patient risk in the support of regulatory documentation.
• Assist development teams in selecting proper materials for use in medical devices.
• Reporting to the Manager-Biological Safety Engineering, you will work cross-functionally and collaborate with R&D, NPD, CRO’s, Regulatory Agencies internal / external scientists and other stake holders.
• This , Pittsburgh, PA, New Kensington, PA or Murrysville, PA based role may require travel up to 10%.
• Company relocation benefits be provided for this position. For this position, you must be within commuting distance to Pittsburgh, PA, New Kensington, PA or Murrysville, PA.

You're the right fit if :

• You’ve acquired a minimum of 1 year experience in Toxicological / Biological Risk Assessments / Test methods for compliance to ISO 10993 (required) and ISO 18562 (desired).
• Your skills include conducting biological assessments and documenting test evidence to support regulatory agency submittals, as well as interaction with Regulatory Agencies to address test strategies and questions related to toxicological assessments.
• You have a minimum of a Bachelor’s degree in Toxicology or related fields (Required), MS or PhD desired. DABT or other health science / medical professional certifications desired.

Knowledge of FDA 2020 Guidance Document Use of International Standard ISO 10993-1 . (Required)

You have experience documenting toxicological risk assessments, analyzing results from Contract Resource Organizations (CRO’s) and communicating with NPD teams and CROs to explain the results of toxicological assessments.

Assist development teams in selecting proper materials for use in medical devices.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
• US work authorization is a precondition of employment. The company consider candidates who require sponsorship for a work-authorized visa, now or in the future.

About Philips :

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.

Do the work of your life to help improve the lives of others.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Last updated : 2024-07-24