Description

In this role, you will lead sterility assurance initiatives, ensuring compliance and quality in manufacturing processes. Your day-to-day responsibilities will involve guiding teams, analyzing data, and collaborating across functions to enhance product safety and performance.

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 with focus on Sterility Assurance
• •5+ years supporting cGMP manufacturing
• •Strong interpersonal and teamwork skills
• •Strong self-management and organizational skills
• •Strong oral and written communication skills
• •Facility start-up and/or technical transfer experience
• •Demonstrated successful leadership of cross-functional teams
• •Experience with data trending and analysis
• •Ability to analyze complex data and solve problems

Tasks

• •Provide leadership for technical and administrative issues
• •Manage performance and development of staff
• •Understand scientific principles for manufacturing parenteral drug products
• •Evaluate manufacturing processes using sterility assurance risk management
• •Assist in developing and executing monitoring strategies for microbial risk
• •Support start-up activities for sterility assurance programs
• •Ensure compliance with environmental monitoring and sterility assurance programs
• •Guide the Process Team in sterility assurance and root cause investigations
• •Analyze microbial and manufacturing data to identify trends and improvements
• •Review environmental monitoring data periodically
• •Lead risk assessments for sterility assurance programs
• •Create and approve technical documents for sterility assurance
• •Evaluate change controls related to sterility assurance programs
• •Educate self and others on regulatory expectations and industry trends
• •Participate in continuous improvement projects for quality performance
• •Define and maintain inspection readiness activities
• •Interact with regulatory agencies during inspections
• •Support technical projects to improve process control and product quality
• •Serve as the sterility assurance interface for the Alzey site
• •Lead cross-functional teams to achieve TS/MS objectives
• •Collaborate with partners across the Parenteral Network
• •Ensure a safe working environment and improve safety culture

Benefits