Senior Toxicologist at Boston Scientific
Senior Toxicologist Job
- Location: Marlborough, MA, US, 01752
- Additional Locations: Remote
Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – High Performance
- At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
- With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About this role:
- The Senior Toxicologist at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives.
- Additionally, this position is responsible for the biological evaluation of medical device products, including the conduct of toxicological risk assessments based on data derived from extractables and leachables studies, in support for new product development and sustaining activities, as well as in support of global regulatory submissions.
- Global Toxicology and Biocompatibility plays a critical role in medical device development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization.
Your responsibilities will include:
- The Senior Toxicologist will provide leadership and guidance on the Biocompatibility and Toxicology process and ensure biocompatibility and toxicology information and data is accurate, reliable, and supports business objectives as consistent with the Global Toxicology/Biocompatibility Organization objectives.
- This position serves as a major resource for biocompatibility and toxicology expertise for medical devices and pharmaceutical products for the assigned business divisions.
- Works closely with R&D, regulatory affairs, quality engineering, and manufacturing, maintaining close communications with internal customers on biocompatibility and toxicology related deliverables.
- Develops testing strategies, coordinates and monitors testing with external research labs, assessing data, and authoring Biocompatibility Assessments and Reports for assigned business divisions.
- Conducts toxicological risk assessments in conformance with established guidance (ISO 10993, ICH, etc.).
- Provides guidance and interpretation of regulatory requirements related to medical device submissions for assigned business divisions
- Additionally, the position directly influences procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs.
- At the basis of every decision, demonstrates a primary commitment to patient safety and product quality.
What we’re looking for in you:
- A MS degree in Toxicology or closely related field, with 3+ years of related experience in the medical device industry
- Working knowledge of the biological evaluation of medical devices and drug-device combination products (ISO 10993 and relevant ICH guidance).
- Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials.
- Applied knowledge and understanding of toxicology principles and best practices, regulatory standards, and global regulatory requirements in the context, especially with respect to medical device and combination products.
- A PhD degree in Toxicology or related field
- DABT or ERT certification
- Excellent written and verbal communication skills
- Must be results and detail-oriented
- Must be able to multi-task while working against aggressive timelines.
- Must be comfortable in a dynamic environment and able to work independently as well as on teams
Requisition ID: 479811
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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