Senior Staff Scientist

Job Description Summary

This position will function within the Toxicology Unit of Corporate Preclinical Development and Toxicology (CPDT) and will support the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the BD CPDT Quality System.

This position manages programs as the business level Subject Matter Expert to address biocompatibility and nonclinical safety of medical devices, pharmaceutical products, and other relevant products produced by BD intended for registration and market by contributing to the development of toxicological evaluation strategies and programs and preparing/reviewing required documentation. The position primarily supports products in the MDS-IPD and MMS Business but may support other products and projects as required.

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Participating in New Product Development projects team/Innovation and sustaining projects meetings as an SME, providing biocompatibility and other CPDT related inputs.
• Review and processing of change control submissions/change documentation.
• Serve as Sponsor Representative for biocompatibility and chemistry studies and contribute to design, execution, and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs for medical devices within BD.
• Author, Review and/or approve Biological Evaluation Plans and Biological Evaluation Reports/Toxicological Risk Assessments to support regulatory filings such as 510(k), EU MDR and global submissions for BD products.
• May lead a small team of scientists supporting project teams.
• Participation in AAMI ISO 10993 Standards Committees and other Industry consortia to represent CPDT Tox and provide inputs on behalf of BD.
• Managing Medical Device Regulations and Standards gap assessment for BD products.
• Work with the counterparts at CPDT to harmonize and improve the risk assessment documentation for BD product portfolio.

• Requires a minimum of a Bachelor’s degree with 10 years of relevant experience;
  Master’s Degree with minimum of 8 years relevant experience; OR Ph.D. with minimum of 6 years relevant experience in Toxicology or closely related field.
• A broad background in biology/biocompatibility, toxicology and chemistry including familiarity with recent methodologies and evaluation techniques (ISO 10993).
• Experience in conducting toxicological risk assessments in accordance with ISO 10993.
• Experience in an FDA regulated medical device setting required.
• Ability to communicate and work effectively across a wide national and international, internal and external client base.
• Working knowledge of computers (Word, Excel, Access, PowerPoint, SharePoint).
• Must have excellent scientific written and verbal communication skills.
• Must be able to multitask and operate effectively within a diverse work environment.
• Must be team oriented and have strong interpersonal skills and customer focus.

• Board certification in toxicology strongly preferred (e.g., DABT, ERT)
• Experience in a GLP preclinical environment preferred.

Fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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