Senior Toxicology Research Scientist

Date: Aug 6, 2022

Location: US-NY-Rochester, New York, US

Company: Bausch & Lomb

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees  and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

 

Position summary:

This Sr. Research Scientist position within the Nonclinical Safety team will support the research and development of new ophthalmic products as well as maintenance of business activities for the B+L Surgical and Vision Care Business Units.  The position will support the design of programs and/or safety strategies, execution of toxicology studies designed to meet regulatory guidelines, particularly ISO 10993, and author biocompatibility safety assessments and other regulatory documents.

 

Key responsibilities:

 

  • The person in this position will serve as a core team member, representing the Nonclinical Safety function providing guidance and risk assessments (products, formulations/ingredients/materials, impurities, leachables and extractables), authoring regulatory documents, and assist in activities related to the management of relevant standards and regulations.  Other responsibilities may include work supporting pharmaceutical products.
  • Design strategies, plan, and manage nonclinical safety/biocompatibility programs
  • Conduct risk assessments on products, ingredients/materials, impurities and formulations, and author safety assessment documents per the requirements of ISO 10993-1, European Union (EU) Medical Device Regulation 2017/745 and other applicable standards
  • Oversee and evaluate activities of Contract Research Organizations
  • Prepare necessary documentation (e.g., Central File Reports. Biological Safety Assessment Reports) to support regulatory submissions
  • Act as a Subject Matter Expert (SME) for ISO and other standards related to the nonclinical group.
  • Conduct gap assessments of ISO standards comparing newly released to recently withdrawn sections.  
  • Conduct gap assessments of products evaluating the reports and documents establishing the biocompatibility of the device with the current regulatory requirements.
  • Assist with routine departmental document archiving activities and those needed to support regulatory submissions
  • Able to travel for CRO study monitoring and professional conferences

 

Qualifications and experience:

  • Bachelor's or Master's degree in Pharmacology, Toxicology, Regulatory Affairs or related discipline  
  • The position requires a minimum of 1 year (PhD) or 5 years (MS, BS) in regulatory toxicology for medical devices; experience with ophthalmic surgical products/equipment highly preferred. 
  • Working knowledge in US and global regulations (e.g. EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
  • Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
  • Experience in managing nonclinical safety studies at external facilities
  • Experience working in Design Control (e.g., PDP) environment
  • Strong computer and general software skills; familiarity with Documentum preferred
  • Knowledgeable and experienced in US FDA Design Control and Change Control requirements.
  • Experience in design, implementation and data analysis of in vitro and in vivo biocompatibility/ toxicology studies to support medical device development for global registration.
  • Basic understanding of good laboratory practice (GLP) regulations.
  • Experience in conducting gap assessment of global standards.
  • Experience in writing safety assessments, researching literature and toxicology database resources, and summarizing information

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This position may be available in the following location(s): US - Rochester, NY (GEHC)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

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