The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site
Job Summary
The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site.
This role is responsible for supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, the gowning certification/recertification program, critical utilities sampling and testing, and overall contamination control program for the site.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Matching Summary
The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site.
Salary
Base: $121,070 - $146,703; Bonus/Equity: Additional incentive cash and stock opportunities; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
Sterility Assurance management
aseptic process validation
contamination control program
regulatory inspections SME
cGMP, FDA, USP, MHRA regulations
Microbiology advanced knowledge
Nice-to-have
team-oriented and cross-departmental
leadership and management skills
mentoring and coaching skills
flexible and adaptable
cell therapy products experience
Key Requirements
2-3 years of leadership/managerial experience
Experience supporting regulatory audits
Experience with Quality Systems
Advanced verbal and written communication skills
Demonstrated critical reasoning and problem solving skills