Associate Director, Method Lifecycle Management

Company Overview

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 that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

We are seeking a motivated Associate Director to lead will include method transfer, qualification, and validation of assays for a range of cell and gene therapy products. The individual will be responsible for managing internal and external GMP method lifecycle including cross functional alignment with Analytical Development, CMC and Internal Support functions.  This role requires strong working knowledge of cell-based methods, experience with flow cytometry, cell count and viability, ddPCR, and ELISA methodologies, and demonstrated experience leading projects that follow ICH/USP guidelines for GMP method implementation. An ideal candidate will also have experience working with hematological samples, next generation sequencing (NGS) and mRNA material.  This role will play a critical role in supporting the advancement of Beam’s cell and gene therapy candidates from early phase to commercialization.

This position will be required onsite 5x/week in Cambridge, MA.

Responsibilities:

• Lead the transfer, qualification, optimization, and validation of methods used for in-process, lot release and stability of cell and gene therapy products and critical materials.
• Onsite presence and travel (10% time) required to ensure appropriate method lifecycle oversight, team leadership (Internal) and at external testing sites.
• Lead small team focused method lifecycle management and routine testing support.
• Independently design, review, approve technical transfer, qualification, and validation protocols to support both internal and external QC methods.
• Work with external partners to ensure successful transfer and execution of release and stability testing methods.
• Identify assay improvement opportunities, and design and execute studies to support assay improvements and process improvements over the lifecycle of the product.
• Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions.
• Work cross-functionally with R&D, Analytical Development, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigations.
• Analyze, track, and trend data to monitor analytical assays, ensure consistency in assay performance, and identify assay improvements throughout the assay life cycle.
• Support Laboratory execution and analyst teams as needed.

Qualifications:

• PhD in Life Sciences, Immunology, Chemistry, or related discipline with 4-6 years of relevant experience, or Master’s degree with 12+ years, or Bachelor’s with 15+ years of relevant experience.
• At least 3-5 years of managerial experience required.
• Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, flow cytometry, cell counting and viability, ddPCR/qPCR, ELISA, and NGS is a plus.
• Direct experience with Deviations, Change Controls, CAPA, etc.) including direct authoring of quality documents and system records.
• Demonstrated track-record of successful QC tech transfers, method qualification, validation and associated data analysis.
• Experience leading GMP release and stability testing and QC laboratory operations and maintenance.
• Experience implementing new methodology, instrument technology and software in a GMP environment.
• Knowledge of and experience with cross functional management of CQV and CSV activities.
• Broad knowledge of ICH/USP guidelines- Specific knowledge and experience with method life-cycle guidance.
• Excellent organizational skills towards multi-tasking in an extremely fast-paced environment.
• Team player with excellent oral and written communication skills.
• Independently motivated, detail-oriented, and excellent problem-solving abilities.