Manager/Senior Manager, Process and Cleaning Validation

The role

This person will provide validation support and leadership for the development of process and cleaning validation programs. They will manage validation strategies, project management, and technical document preparation.

What you will do

• Design and implement approaches for validation studies.
• Lead the development and execution of validation master plans, project plans, protocols, and reports.
• Conduct risk assessments and gap analyses of existing validation programs.
• Evaluate equipment design and manufacturing process procedures to establish acceptance criteria for PQ studies.
• Support regulatory submission efforts and inspection preparation.
• Train client personnel on validation principles, methodologies, and best practices.
• Author, review and approve validation documentation to ensure cGMP compliance.
• Provide technical expertise and leadership in Stage 2 Process Validation projects.
• Escalate technical or schedule issues through functional management and cross-functional governance.
• Manage 3-5 Process Validation and Cleaning Validation direct reports.

Required qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field.
• 6+ years of experience in biopharmaceutical industry supporting manufacturing in a process validation, cleaning validation, process engineering, MST, process development, or other manufacturing suppor
• Experience with quality risk management tools and methodologies.
• Technical writing and documentation skills.
• Project management and communication abilities.
• Experience with managing a team of direct reports.
• Experience with leading a cross-functional project team.

Nice to have

• Experience working with LNP processes and/or process equipment.
• Knowledge of FDA, EMA, and ICH guidelines related to process and cleaning validation or knowledge of how to find/access these regulations.
• Understanding of process design/characterization, equipment design, and CIP/COP systems.
• Familiarity with analytical method development and validation.
• Familiarity with statistical analysis and validation lifecycle approach.
• Familiarity with Smartsheets as a project management tool.

Before you apply

• Must be able to travel up to 25%.

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.