Senior Bio-Tox Scientist I

Summary:

The Senior Biocompatibility & Toxicology Scientist I will be responsible to ensure biocompatibility / toxicology related Quality and Regulatory compliance are met for all Hollister products. The position will support Hollister’s biocompatibility and toxicology program (including policies and procedure).

Responsibilities:

• Solid fundamental understanding on biocompatibility series; ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, and biocompatibility assessment methodology.
• Standards and Regulations Knowledge / Capability - Ability to interpret current Bio/Tox standards, understands impact of external Bio/Tox standards requirements to internal Bio/Tox processes and procedures.
• Project Knowledge / Capability - Capability (with minimal guidance / support) to provide Bio/Tox related change control & NPC/SPRING project support as well as support / provide guidance to lower-level associates.
• Product Knowledge / Capability - Advanced knowledge related to Hollister product portfolio.
• Audit / Supplier Approval & Maintenance Knowledge / Capability - Capability (via audit support experience) to support Bio/Tox lab related supplier re-evaluations & qualifications. Additionally Capability to support external audits of Hollister (e.g. NSAI, FDA) with guidance.
• Complaint Management Knowledge / Capability - Capability to provide Bio/Tox support (with minimal guidance) to the complaint management process (including Bio/Tox related investigation support).
• Problem Solving Knowledge / Capability - Capability (without guidance) to support problem solving and root cause investigations for Bio/Tox laboratory test failures.
• Coaching & Mentoring Knowledge / Capability - Ability to receive and give feedback / guidance as well as on-the-job training to lower-level associates.
• Quality Systems Knowledge / Capability - Demonstrated basic knowledge of medical device quality systems (via “functional lead” experience associated with a single 3rd party internal audit).
• Regulatory Process Knowledge / Capability - Demonstrated basic support capability (via direct “functional lead” experience regarding a Regulatory submission related to a single external body).
• Financial Acumen Knowledge / Capability - Basic understanding of financial analysis related to lab testing as well as impact related to business case and Corporate Objectives. Additionally, basic understanding of the Company Purchase Order system (e.g. COUPA).

Essential Functions of the Role:

• Provide Bio/Tox related change control project support as well as support / provide guidance to lower-level associates.
• Advanced knowledge related to Hollister product portfolio.
• Support Bio/Tox lab related supplier re-evaluations and external audits of Hollister (e.g. NSAI, FDA) with guidance.
• Provide Bio/Tox support (with minimal) to the complaint management process.
• Support solutions to root cause investigations for Bio/Tox laboratory test failures.
• Receive and give feedback / guidance to cross functional and lower-level associates.
• Support Bio/Tox related 3rd party audits.
• Support Bio/Tox related Regulatory activity.
• Support budget compliance and submission of purchase orders to support Bio/Tox testing.

Essential Functions of the Role:

• Lifting – up to 25 lbs.
• Physical dexterity – typing, walking, standing and sitting.

• Ability to travel and drive.

Work Experience Requirements:

• Five (5) years of relevant experience in medical device industry with Bachelor’s degree.
• Three (3) years of relevant experience in medical device industry with Master’s degree.
• Zero (0) years of relevant experience in medical device industry with PhD degree.

Education Requirements:

• Bachelor’s Degree in biology, biochemistry, toxicology, or similar discipline.

Specialized Skills/Technical Knowledge:

• Demonstrates fundamental understanding on biocompatibility series; ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, and biocompatibility assessment methodology.
• Knowledge in Quality Systems standards and FDA Medical Device Regulations (i.e., ISO 13485; QSR).
• Strong Communication Skills.

Local Specifications (English and Local Language):

• English