Scientist III

Scientist III#26-11277 Branchburg, NJ

All On-site Job Description Job Description:

The Senior Scientist I - Biocompatibility is a SME related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of client. This individual must possess an extensive knowledge of

ISO-10993

Standards and prior experience working in biocompatibility. The position will be responsible for cross-functional and cross-site collaborations and recommendations of biocompatibility activities, including establishing requirements, planning, execution and approval of biocompatibility requirements in support of regulatory submissions, project teams, operations, with a large focus on manufacturing and change control (product support).

Responsibilities:

Function as Subject Matter Expert for

ISO-10993

(biocompatibility) assessment management with minimal supervision. This will include the design, execution and interpretation of biocompatibility evaluation strategies and programs according to relevant regulatory requirements, including biological risk assessments, technical reports, technical memoranda and other documents for internal and external distribution, including regulatory submissions. Responsible for creating detailed Project Plans including scientific strategy and realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for the safety characterization of Client and existing products. May serve as a sub-team or core-team member, providing support as needed for all project Teams. Support for on-market products, including global change-control activities as they relate to biocompatibility. Requires interacting with Manufacturing Sites. Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical device and other products. This includes performing gap analysis relevant to changes in biocompatibility standards or guidance. Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives. Build and maintain strong connections and relationships with Contract Research Organizations, Toxicologists and Consultants for Biological Risk Assessments as needed.

Skills:

Strong knowledge of

ISO-10993

Standards, FDA Guidance and Regulations, EU/MDR and Animal Welfare Regulations. Bachelor's Degree in Life Science/Biomedical Engineering or related field with minimal 6 years of experience in a scientific role in the medical device or pharma industry or Master's degree (with thesis) in Life Science/Biomedical Engineering or related field with at least 4 years of experience in a scientific role in the medical device or pharma industry. Strong technical writing and verbal communication skills. Experience managing outsourced contract research (GLP, non-GLP, GMP activities). Understanding of on-market product support with respect to change control and quality systems. Education and Experience Bachelor's Degree in Life Science/Biomedical Engineering or related field with minimal 6 years of experience in a scientific role in the medical device or pharma industry or Master's degree (with thesis) in Life Science/Biomedical Engineering or related field with at least 4 years of experience in a scientific role in the medical device or pharma industry. Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting patient safety studies for R D projects is preferred. Significant experience and knowledge of medical device and combination product regulations Strong knowledge of

ISO-10993

Standards, FDA Guidance and Regulations, and Animal Welfare Regulations. Strong technical writing and verbal communication skills. Experience managing outsourced contract research (GLP, non-GLP, GMP activities). Strong familiarity with the product development process for medical devices or biologics Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data. Self-motivated and proactive; ability to execute with minimal supervision and direction. Can work independently or part of a team. Ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing). Author internal reports and procedures as well as collaborating on manuscripts and abstracts for external submissions. Knowledge of Good Documentation Practices, maintain accurate documentation & related record retention documentation. Knowledge of Good Laboratory Practices (21 CFR, Part 58) and

ISO-10993

standards . Proficient in required software including Word, Excel, PowerPoint, and Outlook, and statistical software.