Beam Therapeutics
Manager/Senior Manager, Process and Cleaning Validation
Cambridge, MA OR Durham, NC · Senior · Full-time
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About the role
- Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
- To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
- This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.
Responsibilities
- Design and implement approaches for validation studies, using knowledge and input from Process Development, Analytical Development, Manufacturing, MST/ENG, and Quality partners.
- Lead the development and execution validation master plans and/or project plans, protocols, and reports for process validation activities.
- Evaluate equipment design and manufacturing process procedures to establish scientifically sound acceptance criteria for PQ studies.
- Support regulatory submission efforts and inspection preparation and address validation-related observations related to process and cleaning validation.
- Manage 3-5 Process Validation and Cleaning Validation direct reports (including contract/consultant support)
Requirements
- Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field.
- Experience with quality risk management tools and methodologies.
- 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.
- Familiarity with analytical method development and validation.
- Familiarity with statistical analysis and validation lifecycle approach.
- Familiarity with Smartsheets as a project management tool.
- Must be able to travel up to 25%.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.