Jobs at Beam Therapeutics

Provides Quality oversight for laboratory, manufacturing, QC, and facilities operations at a cell and gene therapy manufacturing site. Responsibilities include shop-floor presence, batch and logbook review, GMP compliance, product disposition, deviation and CAPA approval, work-order and asset approvals, quality-system improvements, tech transfers, equipment qualification and validation, issue resolution, metrics, and regulatory inspection support. Requires onsite work and a flexible schedule, including alternate shifts.

Leads Beam Therapeutics’ Massachusetts GMP Quality Control organization, overseeing release, stability, method qualification, validation, and transfer testing. Manages QC staff, laboratory investigations, deviations, change controls, CAPAs, data integrity, equipment and system readiness, training, inspection preparation, and continuous improvement. Partners cross-functionally to support clinical manufacturing, commercial and BLA readiness, regulatory inspections, and compliant laboratory operations.

Administer and enhance Beam’s LabVantage LIMS, LES, SDMS, instrument integrations, Attachment Handler configurations, and laboratory automation systems. Partner with QC, QA, IT, validation, and laboratory scientists to digitize workflows, manage data integrity, support integrations, troubleshoot issues, and deliver compliant GMP and non-GMP solutions. Support CSV, GAMP 5, 21 CFR Part 11, audits, inspections, documentation, training, governance, and continuous improvement.

Support cGMP cell therapy manufacturing operations across multiple production areas, serving as an operational lead and trainer. Maintain training qualifications, revise equipment SOPs, draft change controls, manage small area projects, and perform limited commissioning, qualification, and validation tasks for facility expansions or upgrades. The role requires cross-functional collaboration, GMP experience, cleanroom work in ISO 5/Grade B environments, and daily onsite availability with schedule flexibility.

The Vice President, Compliance oversees the Corporate Compliance Program, ensuring regulatory adherence, managing clinical supplies, and fostering a culture of accountability.

Lead commercial engagement with Authorized Treatment Centers, driving site onboarding, operational readiness, and sustained therapy utilization. Develop strategic account plans, build executive relationships, coordinate cross-functional field pods, analyze utilization and referral trends, and represent the company at conferences to meet demand and activation targets.

Provide contracting and legal support for commercialization: draft and negotiate commercial agreements with treatment centers, partners and manufacturers; review pre-commercial activities and promotional materials; manage contract lifecycle and risk; update contracting playbooks; and draft licensing, collaboration, clinical trial and sponsored research agreements.

Lead state government affairs strategy to influence legislators, governors, and state Medicaid officials; build state-level networks; coordinate lobbying and advocacy; advise on federal/state policy risks and opportunities; collaborate with market access, regulatory, and patient advocacy teams; travel as needed.

Provide high-level administrative support to the CFO and CSO including extensive calendar management across time zones, meeting logistics, expense and travel management, purchase order requests, preparing materials and presentations, handling confidential information, coordinating with other administrative staff, and completing ad hoc projects.

Lead the Project Management function and manage the BEAM-302 program, aligning cross-functional teams on strategy, timelines, budgets, risks, and deliverables. Oversee portfolio integration, governance support, scenario planning, risk mitigation, and operational excellence initiatives. Drive adoption of best practices and AI/tools to improve consistency and execution, and communicate program status to leadership and stakeholders.

Lead CMC strategy and execution for in‑vivo and ex‑vivo programs from IND through BLA. Oversee process and analytical development, manufacturing scale‑up, regulatory CMC submissions (Module 3), risk management, cross‑functional teams, CDMO oversight, and ensure cGMP/ICH compliant product lifecycle strategies.

Lead strategy and execution for potency and analytical assay development and drug product development (including LNPs) from IND through BLA. Manage and mentor assay teams, partner with CMC, QC, QA, and manufacturing, support regulatory submissions and meetings, oversee risk management and compliance with cGMP/ICH, and drive cross-functional product lifecycle execution.

Lead sponsor-side clinical data management for assigned studies from start-up through database lock. Oversee CRO/vendor data activities, ensure CDASH/CDISC/SDTM-compliant CRF and database design, manage edit checks, reconciliations, query resolution, and inspection-ready documentation. Track metrics, mitigate risks, and collaborate with Clinical Ops, Biostatistics, Medical, Regulatory, and Quality to support study objectives and regulatory submissions.

Lead design, delivery, and management of global GMP/GxP training programs and related systems. Support QMS improvements, computer system validation, training metrics, CAPA/change control management, audit preparation, and stakeholder guidance to ensure regulatory compliance and training effectiveness.

The Associate Director/Director of Toxicology leads nonclinical safety assessments, oversees study execution, and supports regulatory filings for gene therapy programs.

Lead pharmacovigilance activities for Beam products, providing scientific and operational PV support across clinical development and lifecycle. Oversee safety monitoring, ICSR assessment, signal detection, aggregate reporting, vendor management, inspection readiness, SOP development, cross-functional safety governance, database migrations, and PV training. Act as PV SME and contribute to PV strategy, quality, and compliance.

Lead study-level biostatistics for clinical trials: design, SAPs, TLFs, CRF and randomization review; oversee CRO biometrics and programmers; perform analyses, support regulatory submissions, and collaborate cross-functionally.

Lead Beam's metabolic clinical development as medical head for base-editing gene therapies. Set strategy, design clinical plans, oversee trial execution and patient safety, interact with regulators, support R&D and business development, and manage/mentor physician and clinical scientist teams.

The role leads global supply chain planning, ensuring uninterrupted supply of products, inventory management, and effective collaboration with cross-functional teams.