Posted on : Thursday, April 6, 2023 Organization : Bausch + Lomb Location : Rochester, NY Description :
This principal scientist position within Nonclinical Safety will support the research and development of new ophthalmic products for Vision Care and Surgical Business Units through the design of programs, preparation of safety strategies and execution of toxicology studies designed to meet Regulatory guidelines, particularly ISO 10993.
The person in this position will serve as a core team member, representing the nonclinical safety function, on project teams.
Additional responsibilities of this position will include providing guidance and risk assessments on new formulations / ingredients and leachable / extractables, preparing Regulatory-acceptable submission documents, interacting with Health authorities, and support maintenance of business activities.
Other responsibilities may include supporting the safety of pharmaceutical products, providing guidance and risk assessments associated with industrial hygiene, workplace safety and environmental toxicology issues.
Specific Job Duties :
- Design strategies, plan, and manage Nonclinical Safety programs.
- Represent the Nonclinical Safety function on project teams.
- Prepare risk assessments on key ingredients, impurities, and formulations.
- Oversee and evaluate activities of contract research organizations.
- Prepare necessary documentation to support regulatory submissions.
The position interacts directly with B+L functional groups including R&D groups in Rochester, Waterford, Wilmington, Greenville, St.
Louis, Irvine, and Clearwater. Also, interacts with internal functions such as Regulatory Affairs, Analytical Chemistry, and Quality groups in the various business units.
Requirements : Qualifications :
Qualifications :
- The position requires a Master’s degree (PhD preferred) in a related field, including toxicology or other biological sciences.
- The position requires a minimum of 3 years with a PhD or 5 years with a Master’s degree in medical devices regulatory toxicology;
experience with ophthalmic products preferred.
- Expert of regulations and requirements for safety testing, particularly ISO 10993.
- Experience in managing nonclinical safety studies at external facilities.
- Experience working in Design Control PDP) environment.
- Strong computer and general software skills; familiarity with Documentum preferred.
- Strong oral / written communication skills.
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