Manager/Senior Manager, Process and Cleaning Validation

Beam Therapeutics Inc.; Salem (OR); On-site; USD 150,000 - 190,000; Full time

Job summary

Beam Therapeutics Inc. 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. The position emphasizes leading development of validation master plans, risk assessments, and acceptance criteria, with collaboration across Process Development,

Qualifications

• Bachelor’s degree required in Engineering, Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 8 years in biopharmaceutical process validation, cleaning validation, or manufacturing support.
• Experience with quality risk management tools and methodologies.
• Strong technical writing and documentation skills.
• Proven 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).

Responsibilities

• 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

Skills

Project management

Cross-functional leadership

Technical writing

Documentation skills

Quality risk management

Regulatory compliance

Team leadership

LNP processes

Education

Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field

Job description

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.

Responsibilities

• 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

Requirements

• 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)