Biocompatibility & Toxicology Director
Canyon Labs · Rochester, New York Metropolitan Area
Apply & track with Apply EdgeCanyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, packaging, and biological and analytical testing.Canyon Labs is seeking an experienced Biocompatibility & Toxicology Director to lead our biological safety and toxicology programs supporting sustaining and new medical device products and pharmaceuticals.
The Director supervises all Biocompatibility & Toxicology personnel, ensures proficient and efficient practices, and provides career development and training for Biocompatibility & Toxicology personnel. The Director builds and maintains technologies necessary to serve clientele and has responsibility for department compliance with applicable regulatory guidance documents.The Director supports QA policies and directives and ensures compliance with associated processes. The Director interfaces with clients regarding technical issues and builds external scientific and client relationships. The Director also provides technical expertise to the department.Key ResponsibilitiesTechnical duties:Develop or supervise development of study designsPrepare, review, and approve GMP and GLP protocols and reportsProvide scientific expertise for the interpretation and evaluation of results generated in the Toxicology departmentReview data generated by Toxicology personnel:Develop, validate, and document methods as neededInterface with clients as neededAct as Test Facility ManagementManagerial duties:Identify and manage staffing requirements and assignments, including routine review of the department schedule to verify the workload is achievable in a compliant and balanced manner.Implementation of processes and activities defined by executive leadership.Supervise technical personnel and delegate responsibilities.Ensure in-process test documentation audits are performed and documented to verify complete and contemporaneous documentation of test data.Evaluate equipment and resource requirements, plan and recommend capital expenditures as necessaryFacilitate process improvementsInterface with clients as needed – building client baseWork with Client Services to support quote preparationPrepare and/or review Regulatory and Quality documentationResponsible for on-time completion of quality events to which they, or someone in their area of oversight, is assigned as owner. Reinforce the on-time delivery expectation through personnel performance assessments and routine one-on-one meetings with direct reportsOversee and participate in audits and site inspectionsOversee the animal care and use programForecast and manage department budgetAll other duties as requested by managementQualificationsAdvanced degree in Toxicology or related field (PhD and/or DABT) preferred with 10+ years of relevant experience including management of personnel.Canyon Labs offers several benefits as part of your total compensation, including but not limited to:Paid Time Off, Sick Time, and Paid HolidaysMedical, Dental and Vision InsuranceLong term disability insurance, life insurance401(k) with company match up to 4%At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.