The Sr. Manager – TSMS Sterility Assurance is responsible for providing technical leadership, management and mentorship for a team of sterility assurance scientists and technical staff while ensuring compliance with regulatory requirements and industry best practices
Job Summary
The Sr. Manager – TSMS Sterility Assurance is responsible for providing technical leadership, management and mentorship for a team of sterility assurance scientists and technical staff while ensuring compliance with regulatory requirements and industry best practices.
Key objectives include leading and developing a team of sterility assurance scientists which support floor activities associated with start-up and compliant manufacturing, particularly as it relates to development and implementation of sterility assurance strategies.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
Matching Summary
The Sr. Manager – TSMS Sterility Assurance is responsible for providing technical leadership, management and mentorship for a team of sterility assurance scientists and technical staff while ensuring compliance with regulatory requirements and industry best practices.
Salary
$99,000 - $145,200; Bonus: Company bonus; Benefits: Comprehensive benefit program
Skills & Requirements
Must-have
sterility assurance strategies
environmental monitoring
aseptic process simulations
facility cleaning and sanitization
sterility assurance risk management
cGMP manufacturing support
Nice-to-have
technical leadership and mentorship
collaborative workplace
root cause investigations
deviation management
audit and inspection readiness
Key Requirements
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Prior experience in cross functional technical leadership roles
In depth knowledge of parenteral drug product manufacturing