The Senior Manager leads and participates in facility and process validation activities, including process tech transfers and lifecycle management changes
Job Summary
The Senior Manager leads and participates in facility and process validation activities, including process tech transfers and lifecycle management changes.
Responsible for leading Process Validation activities including, but not limited to Product Lifecycle Management changes, Process Performance Qualifications (PPQ), microbial hold studies, and comparability studies.
Benefits include Health Coverage, Wellbeing Support, Financial Well-being and Protection, and Work-life benefits such as Paid Time Off and Global Shutdown.
Matching Summary
The Senior Manager leads and participates in facility and process validation activities, including process tech transfers and lifecycle management changes.
Salary
Base: $139,480 - $169,013; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
cGMP's and biopharmaceutical regulations
facility and process validation
process tech transfers
product lifecycle management
data analysis and statistics
cGMP operations and inspection readiness
Nice-to-have
culture of proactive problem prevention
collaborative relationships across teams
strategic thinking and action translation
Key Requirements
Minimum 8 years biopharmaceutical operations experience
Hands-on cGMP manufacturing experience
Bachelor's degree in science, engineering, or related discipline