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 and safety strategies as well as execute toxicology studies designed to meet Regulatory guidelines, particularly ISO 10993.
This person in this position will serve as core a 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 document, interacting with Health authorities, and other maintenance of business activities. Other responsibilities may include supporting 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
• Conduct risk assessments on key ingredients, impurities and formulations
• Oversee and evaluate activities of contract research organizations
• Prepare necessary documentation (e.g. Central File Reports) to support regulatory submissions
Scope of position:
This position, based in Rochester, NY is primarily focused on the development of new vision care (i.e. contact lenses and contact lens care products) and surgical products as well as supporting maintenance of business.
The position interacts directly with B+L functional groups including R&D groups in Rochester, Waterford, Wilmington, Greenville, St. Louis, Irvine and Clearwater. Also B&L Regulatory, Analytical Chemistry, and Quality groups in the various business units. May include work on other Valeant (non-B&L) medical devices as needed.
The position requires a Master degree (PhD preferred) in a related field, including toxicology or other biological sciences.
The position requires a minimum of 5 years in regulatory toxicology for medical devices; experience with vision care 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 (e.g. PDP) environment
• Strong computer and general software skills; familiarity with Documentum preferred
• Strong oral/written communication skills
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