Manager/Senior Manager, Process and Cleaning Validation

Beam Therapeutics · MA OR Durham, NC

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Role summary

Beam Therapeutics seeks an experienced Process and Cleaning Validation Manager or Senior Manager to lead validation strategy and execution for genetic medicine manufacturing. The role requires designing validation approaches, managing teams, and ensuring regulatory compliance across internal and external manufacturing processes.

What they're looking for

Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field
Minimum 8 years biopharmaceutical industry experience in process validation, cleaning validation, or manufacturing support
Proficiency with quality risk management tools and methodologies
Strong technical writing and documentation skills
Project management and cross-functional team leadership experience
Team management experience with direct reports
Experience with LNP processes and FDA/EMA/ICH validation guidelines (preferred)

What you'll be doing

Design and implement validation study approaches collaborating with Process Development, Analytical, and Manufacturing teams
Lead development and execution of validation master plans, protocols, and reports for process validation activities
Conduct risk assessments and gap analyses to identify validation program improvements
Establish scientifically sound acceptance criteria for equipment qualification studies
Support regulatory submissions, inspections, and validation-related compliance matters

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