Beam Therapeutics · 1 week ago
Senior Associate, Process and Cleaning Validation
Durham, NC
Full-time
Hybrid
Mid, Senior Level
$80K/yr - $101K/yr
6+ years expBeam Therapeutics is a biotechnology company focused on precision genetic medicines. The role involves providing validation support for process and cleaning validation programs, including the development of strategies and technical documentation.
BiotechnologyGeneticsMedicalTherapeutics
Responsibilities
Design and implement approaches for validation studies, using knowledge and input from Process Development, Analytical Development, Manufacturing, MST/ENG, and Quality partners
Develop and execute validation master plans and/or project plans, protocols, and reports for process and cleaning validation activities
Conduct risk assessments and gap analyses of existing validation programs to identify areas for improvement
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
Train client personnel on validation principles, methodologies, and best practices
Author, Review and approve validation documentation to ensure compliance with cGMP requirements
Provide technical expertise in cleaning agent selection, residue detection methods, and recovery studies
Support technology transfer activities and process scale-up initiatives involving Process or Cleaning Validation Programs for internal and external manufacturing initiatives
Qualification
Required
Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field
Minimum 6 years of experience in biopharmaceutical industry supporting manufacturing in a process validation, cleaning validation, process engineering, MST, process development, or other manufacturing support related capacity
Experience with quality risk management tools and methodologies
Technical writing and documentation skills
Project management and communication abilities
Must be able to travel up to 25%
Preferred
Experience working with LNP processes and/or process equipment
Experience with managing a team of direct reports
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
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2026-01-13
thefly.com
2026-01-13
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