Overview Beam Therapeutics seeks an experienced Process and Cleaning Validation SME to lead validation programs for early manufacturing processes. You will design and oversee validation master plans, risk assessments, and execution with cross-functional partners, while ensuring cGMP compliance. The role includes regulatory submission support, training, and robust documentation development. Lead Stage 2 validation efforts, manage a small team, and collaborate with internal and external manufacturing to drive quality and scale.
Responsibilities- Design and implement validation study approaches with cross-functional input
- Lead development and execution of validation master plans, protocols, and reports for process validation
- Conduct risk assessments and gap analyses of existing validation programs
- Evaluate equipment design and manufacturing procedures to establish acceptance criteria for PQ
- Support regulatory submissions and inspection readiness; address validation observations
- Train client personnel on validation principles and methodologies
- Author, review and approve validation documentation to ensure cGMP compliance
- Provide technical leadership in Stage 2 Process Validation projects for internal and external manufacturing
- Escalate technical or schedule issues within management and governance structures
- Manage 3-5 direct reports (including contract/consultant support)
Key requirements- Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field
- Minimum 8 years in biopharmaceutical manufacturing support in process validation, cleaning validation, process engineering, MST, or related roles
- Experience with quality risk management tools and methodologies
- Technical writing and documentation skills
- Project management and strong communication abilities
- Experience managing a team and leading cross-functional projects
- project management
- cross-functional collaboration
- written and verbal communication
- cGMP knowledge
- process validation and cleaning validation
- risk management tools
