Job Description SummaryWithin Medical Affairs of BD Medical Pharmaceutical Systems, Toxicologist contributes to the Safety of BD products under Advanced Drug Delivery System (ADDS) platform, creating and coordinating strategy for product development and to the risk management starting from the conception phase until the end-of-life cycle. Sustains a scientific culture focusing on product safety as well as health risk prevention, regarding toxicological evaluation and patient safety. Applies subject matter expertise to solve complex biocompatibility problem, utilizing technical experience and independent judgment.
Reporting to Medical Affairs ADDS Platform Lead, closely communicates with Product Safety Engineers, Product Safety Manager and Corporate Preclinical Development & Toxicology (CPDT). On the platform level functions as a key team member collaborating with associates from diverse technical backgrounds.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Leads development and implementation of the MA strategy on Safety side for the platform. Ensure those are aligned with the needs of product development.
Collaborates with customers from the pharmaceutical industry or the notified bodies and Health authorities on biological evaluation topics.
Provides guidance regarding product conception by conducting appropriate analyses and drafting risk assessments.
As a subject matter expert for biocompatibility of medical devices, performing EU MDR remediation by reviewing data and authoring and/or reviewing biological evaluation plans, biological evaluation reports and biological/toxicological risk assessments to prepare for submission to notified bodies
Prepare biological safety evaluation plans for medical device program testing
Provide biological risk assessments for biocompatibility data, toxicological risk assessments for chemical characterization data (including literature searches)
In collaboration with Product Safety Manager and CPDT, ensure biocompatibility and chemical characterization studies are following the most recent regulatory requirements
Provides responses on product safety requests either internally or externally. This includes risk assessment during product development, defining the product use conditions, and/or performing analyses or literature review for risk characterization
Contributes to the improvement of the process of product safety assessment, share toxicological experience within the team and bring your medicinal drug knowledge to the large Medical Affairs team.
Provides mentoring for new comers as well as junior members of Safety team on biocompatibility/toxicology topics.
Specific diploma/certification in toxicology, ERT or DABT. Experience in chemical risk assessment (extractable).
Strong skills in biology and chemistry. Demonstrated competence in research field with a specific emphasize on toxicology, biochemistry, immunity, microbiology, cellular and molecular biology.
Ability to understand and interpret statistical data (e.g. tables, graphs)
Ideally already trained to ISO10993 standard: knowledge and field practice of the standard
Nice to have knowledge of common materials of concern regulations (US, EU, Asia): REACH, California Prop 65, Latex, phthalates…
Curiosity outside of own field of knowledge
Knowledge and experience in health risk management activities, knowledge in medical device and pharmaceuticals industry (design control, ICH, GLP, GMP, REACH, ISO14971, USP …)
Excellent written and verbal communication skills in English
Critical thinking, able to conduct rigorous analysis, understanding of other’s needs.
Experience in mentoring/managing people
Proficient in Microsoft Word, Microsoft Excel, Adobe programs.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
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Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ