We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology it is all we do combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.
Position Summary:
The Environmental Health and Safety Specialist is responsible for developing, implementing, coordinating, and maintaining a comprehensive safety program across pre-clinical research and animal areas at TD2. These responsibilities include but are not limited to implementation and review of safety policies and procedures; risk assessments and management; inspections, training and regulatory and third-party compliance and oversight. This role reports to Senior Manager, Nonclinical Operations.
Essential Functions:
Administer the TD2 Environmental Health and Safety program through development, maintenance, implementation, review, and continual update of internal safety policies and procedures.
Enforce the safety program in accordance with local, state, and federal. Stay up to date on current and emerging laws, regulations, and trends in environment and safety (EPA, OSHA, USDA, CDC).
Develop, deliver, and track training for employees. Training must cover the hazards encountered, applicable regulatory requirements, safe work practices, and containment equipment for the safe use, storage, and disposal of a variety of hazards including biological, chemical, physical and environmental hazards.
Create task specific training materials or other educational resources for related programs such as hazardous materials shipping, hazardous waste management, controlled substances use in research, and ergonomics.
Perform detailed risk assessments and provide requirements and recommendations to Department Leadership, laboratory management, laboratory personnel, and animal care staff. Review experimental and protocol set-ups (including animal research) and assess for safety.
Verify that facilities, procedures and practices, training and personnel expertise follow federal, state, and local requirements, as well as internal procedures. Provide input for laboratory set-up, equipment installation, new build outs and renovations.
Maintain and update TD2s Safety Data Sheet (SDS) database.
Oversee the collection and disposal of chemical and biological hazardous waste.
Coordinate and perform annual audits and supplemental laboratory safety inspections to ensure appropriate health and safety precautions and containment equipment are in place, and that laboratory standards are rigorously followed. Prepare written reports outlining corrective measures when applicable.
Administer the occupational health and safety program by coordinating activities with outside occupational health support.
Respond to various requests for environmental health and safety services throughout TD2s facility, including PPE review, laboratory space issues, hazardous waste collection consultations, work process consultations, noise assessments, hazmat shipping requests, and various related activities.
Assist in implementation of policies as they relate to the Institutional Animal Care and Use program (IACUC). Review IACUC protocols to ensure animal safety practices and procedures are incorporated.
Ensure coordination with the IACUC administrator where animal care and use protocols have biosafety and/or hazardous materials compound components.
Assist in preparation of the vivarium and laboratories for and participation in audits and inspections.
Act as a liaison with Human Resources and/or upper management for the reporting of all significant problems, violations, deviations from biosafety and chemical safety protocols and any significant research-related accidents or illnesses.
Respond to emergencies and perform post-incident reporting and corrective actions. Analyze accident patterns and determine appropriate actions to reduce or eliminate safety hazards.
Provide support in the submission, maintenance, and renewal of regulatory permits as needed. Assist in coordinating and preparing various IACUC correspondence/reports.
Perform other duties as assigned.
Job Requirements:
Masters degree in Life Sciences, Occupational Safety, Environmental Health, or related discipline and 2 years of animal biosafety/safety research related experience or Bachelors degree in Life Sciences, Occupational Safety, Environmental Health, or related discipline and 3-5 years of animal biosafety/safety research related experience.
Previous experience in a laboratory, quality management, or research compliance environment.
Proven ability to navigate and understand regulatory language and code.
Understanding of environmental, health and safety principles and practices.
Familiarity with typical biological and chemical hazards found in a laboratory.
Experience in an animal research environment (rodents).
Professional working knowledge of creating and implementing new process, procedures, and policies.
Required Specialized/Technical Skills:
Proficient with Microsoft Office products including Word, PowerPoint and Excel.
Strong attention to detail.
Open to change, comfortable working in ambiguous situations, and responding to new information and unexpected outcomes.
Excellent oral and written communication skills.
Ability to present information in one-on-one and group situations.
Ability to interact with others in a positive, productive way including personnel in diverse positions including scientists, researchers, technicians, and administrative personnel.
Ability to work independently.
Able to lift 50 pounds or more (infrequent) and work around hazardous biological and chemical hazards.
Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veterans status, gender, sexual orientation, gender identity, or gender expression.
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