Manager of Toxicology supporting the conduct of medical device and pharmaceutical testing and departmental processes. Supervise and provide training for toxicology personnel. Responsible for study compliance with applicable Regulatory guidance documents (i.e., ISO and GMP) and QA policies and directives. Responsible for interfacing with clients regarding technical issues. Provide technical expertise to the department. Serve as study director and conduct laboratory work as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Supervise technical personnel and delegate responsibilities
- Manage training within the department
- Interface with clients as needed –technical issues
- Develop complex protocols and prepare and approve reports as needed
- Serve as Study Director on Research and GLP/GMP studies
- Conduct laboratory work as needed
- Conduct laboratory investigations and manage deviations
- All other duties as requested by management
EDUCATION and/or EXPERIENCE
Masters degree in Toxicology or related science or equivalent experience/education combination. Five years+ experience required. Strong expertise and experience with conducting Toxicology studies, method development and strong knowledge of testing requirements for pharmaceutical and medical devices.
Word processing, spreadsheets, statistics.
Both oral and written to company, clients, and to professional organizations.
Math skills required with ability to understand and manipulate simple to complex equations including exponential and logarithmic functions. Must know basic statistical analysis.
Technical problem solving including evaluation of results and issue management.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit, stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear. The employee may occasionally be required to climb, balance, stoop, kneel crouch or crawl. The employee is occasionally required to sit.
The employee must occasionally lift and/or move up to 30 pounds. Specific vision ability includes close, distance, color, peripheral, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Combination of Office and Laboratory settings
iuvo Bioscience is an Equal Opportunity Employer.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.