The posting
Why Join Bracco Medical Technologies?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
The Sr. Scientist, Toxicologist will have responsible for providing leadership and support for biocompatibility and chemical characterization testing encompassing extractable and leachable analysis and evaluating the harmful effects of chemicals on Bracco Medical Technologies (BMT) products, determining the safe exposure levels, and ensuring compliance to BMT design control procedures and applicable regulations and external standards.
Primary Duties & Responsibilities:
- Support biocompatibility and other chemical and toxicology testing for consumable devices to identify, understand, and assess the toxic effects of identified chemicals and substances on patients supported by BMT products.
- Interpreting data from studies, drawing conclusions, and making recommendations for safety and regulatory compliance.
- Advising on safe exposure levels for substances identified in BMT products.
- Collaborating with project teams and testing facilities in the development of testing required for assessment of biocompatibility.
- Providing expert advice in legal and regulatory matters related to toxicology.
- Lead Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993.
- Conduct toxicological risk assessments supporting product development, design changes, supplier changes, and regulatory submissions.
- Provide technical leadership for extractables and leachables (E&L) studies, including protocol development, data review, and report approval.
- Partner with R&D, Design Assurance, Regulatory Affairs, and Supplier Quality to integrate biological safety throughout the product lifecycle.
- Monitor emerging regulatory requirements and maintain internal biological safety procedures, standards, and best practices.
Does this position have supervisory authority? Yes ☐ No ☒
Qualifications (Knowledge, Skills & Abilities):
Minimum
- Bachelor’s degree in Toxicology, Chemistry, Biology or other related technical / scientific background
- 10+ years of experience in Toxicology or a related field.
- Board certified toxicologist (DABT or equivalent) is required.
- Working knowledge of the FDA Quality System Regulation and EU Medical Device Regulations.
- Experience performing toxicological risk assessments and biological evaluations in accordance with ISO 10993 and ISO 14971.
- Knowledge of extractables and leachables (E&L) studies, analytical chemistry techniques, and interpretation of analytical data.
- Moderate level of computer proficiency including MS Word, Excel, Project, and statistical applications software.
- Effective oral and written communication skills.
- Effective technical writing skills.
- Ability to work independently and prioritize assignments to meet project timelines.
Preferred:
- Masters degree plus 7 years in Toxicology or a related field, or PhD in Toxicology plus 3 years of experience in Toxicology or a related field.
- Demonstrated knowledge of ISO 10993 series of standards.
- Experience authoring Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), and supporting FDA, MDR, and other global regulatory submissions.
- Experience managing external testing laboratories and collaborating with cross-functional teams throughout the medical device product lifecycle.
Other:
- Travel expected to be less than 10%.
Compensation & Total Rewards:
Estimated Starting Salary Range: $160,000 - 173,000
*Estimated salary is intended to reflect the salary Bracco Medical Technologies reasonably expects to pay for the position. The provided range is based on salary and market data and may vary based on an employee's eligibility for geographic differential pay in high-cost-of-labor markets.
Total Rewards:
- Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
- Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
- Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
- Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
- Choose –You won’t find “stuffy” here whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.
Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.
