Position Overview:

Beam is looking for a highly talent and motivated Senior Specialist, Product Quality Assurance to join our growing Quality team. The Senior Specialist, Product Quality Assurance will be responsible for supporting Quality's oversight of laboratory and manufacturing operations at Beam's manufacturing facility in Durham, North Carolina. Beam's manufacturing facility is focused on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility is currently focused on clinical phase manufacturing with the intent of moving several programs to be commercial within the same facility. Reporting into the Director, Product Quality Assurance, this role will provide Quality oversight of routine manufacturing, testing, and related operations to ensure that systems and processes are maintained in compliance with Good Manufacturing Practices (GMP), and ultimately to Good Distribution Practices (GDP) as the programs move to the commercial phase. This role will also provide Manufacturing Shop Floor Quality presence and may require support on first or second shift as required by plant scheduling.

Primary Responsibilities:

• Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations.
• Provide Quality oversight of QC testing.
• Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations.
• Responsible for assisting with product disposition activities of supply produced at the manufacturing facility.
• Real time review of batch records and labels.
• Review and approval of manufacturing discrepancies and associated CAPA’s.
• Communicating lot disposition pending issues to management.
• Aid in the development and ongoing improvement of applicable quality systems for the site; identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed.
• Review and approve calibration and maintenance work orders and asset inductions.
• Support approval of protocols when required.
• Provide Quality support towards resolution of material, product, environmental, facility and equipment manufacturing issues.
• Responsible for supporting functional and facility goals and objectives.
• Responsible for supporting and contributing to quality metrics for the facility.
• Responsible for supporting and participating in regulatory inspections.
• Responsible for communication and escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or company impact to senior management.

Qualifications:

• Bachelors or Advanced degree in a scientific discipline with 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
• Knowledge of aseptic processing, and/or cell and gene therapy is preferred.
• Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
• Knowledge of global regulations and standards.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually as well as within a multi-disciplinary team.
• Excellent listening, communication and interpersonal skills with a team focus.
• Consistent delivery of high-quality work.
• Ability to gown and work in a cleanroom environment.
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
• Ability to support 2nd shift schedule.

Position Overview:

The Senior Facility Technician, Instrumentation and Calibration is a multi-disciplinary role whose primary focus will be performing calibrations on Facility, Utility, lab, and Process Equipment to include management of standards and optimization of maintenance and calibration procedures. In addition to this primary responsibility, secondary responsibilities include supporting the overall maintenance of Facility and Utility Equipment by completing maintenance activities outside of calibrations; additionally, this role will support the 24x7 support strategy by being apart of the “on call” program. In addition to a varied general maintenance background, the ideal candidate should also possess the ability to work with personnel from Quality, Validation, Laboratories, IT, Finance, and Administration.  This is a M-F Day Shift Position subject to after hour and weekend support.

Responsibilities:

• Extensive experience with performing calibrations on Utility, Lab, and Process Equipment. Examples include: pressure, flow, velocity, temperature, pH, conductivity, weight, time, gas systems, etc.
• Experience with the management of instrument standards.
• Drive change and champion continuous improvements by improving calibration procedures.
• Execute planned and demand maintenance activities for plant utilities (HVAC, Electrical, Chilled/Heating Hot Water, Compressed Air), gene therapy manufacturing equipment, and QC laboratory instrumentation.
• Support CapEx and Process Improvement project initiatives as required.
• Coordinate and schedule vendors for maintenance and calibration tasks.
• Respond and remediate alarms from the Building Automation and Process Control systems and site equipment.
• Create individual work and review vendor work within the site CMMS system.
• Ensure compliant operations in accordance with site cGMP, environmental, and government requirements.
• Ability to participate in on-call rotation with members of the Facility Maintenance team.

Qualifications:

• Post-secondary degree, certification(s), or equivalent experience in a technical discipline related to MEP, construction, utilities, or trades. Supervisory experience with technicians &/or vendors preferred.
• 8-10 years’ experience in calibration and maintenance with a preference for biotech, pharma, or medical device manufacturing.
• Working knowledge of process equipment, utility systems, and lab equipment.
• Computer systems literacy, with Siemens BAS, DeltaV, and CMMS experience required.
• Ability to manage competing priorities and timelines and adapt quickly to changing circumstances.
• Flexible and results oriented, with a focus on excellent customer service and demonstrated collaboration in a team environment.
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.

Position Overview:

The QC Manager, Raw Materials will be responsible for developing, leading, and managing the Raw Materials QC program at the Beam Therapeutics Manufacturing facility in Durham, NC. This role will develop and maintain documentation regarding testing requirements and strategies, serve as a subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry practices. This person will have knowledge and experience with USP methods, and the ability to apply as required, and as well as maintaining compliance to USP, ICH and FDA guidance documents. Interface with Manufacturing, Supply Chain, and Quality Assurance leadership and participate and/or lead interdepartmental teams to address quality-related issues.

This role requires on-site presence and engagement. The position will report to the Quality Control Senior Director.

Primary Responsibilities:

• Build and manage the raw materials QC program at the Beam Therapeutics Manufacturing facility.
• Develop and maintain all documentation with regards to testing requirements and strategies, including material specifications.
• Serve as a SME for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices.
• Manage contract laboratories as needed.
• Own and author risk assessments for raw material programs.
• Support supplier change notifications and material enrollment.
• Identify need for development of new assays with compendial and GxP requirements.
• Accountable for managing the raw materials testing program to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents.
• Evaluate QC systems and recommend and/or implement system improvements.
• Author technical protocols and reports for Raw Materials testing qualification, validation, or verification.
• Author test methods and SOPs for the Raw Materials testing program.
• Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
• Manages release of raw materials used in manufacturing.
• Provide oversight of material master data as it relates to inspection plans and material life cycle.
• Maintain records and databases in accordance with procedures.
• Hire and manage staff as needed.
• Oversee management of in-house raw material test equipment.

Qualifications:

• Bachelor’s or advanced degree in biology, biochemistry or closely related scientific discipline.
• At least 7-10 years of CGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
• Expert knowledge of pharmaceutical/biotech Raw Materials testing is required.
• At least 3 years of management experience is required.
• Basic knowledge of qualifications and validations; current industry practices; and strong experience with guidance interpretation and application.
• Knowledge of cGMPs, ICH, USP, FDA requirements is required, including equipment and method validation/verification.
• Experience with risk assessment tools is desired
• Excellent critical thinking and technical writing skills.
• Excellent interpersonal and communication skills to lead, facilitate and follow.
• Computer skills required to use Microsoft Word, Project, Visio, and Excel programs.

Position Overview:

The Senior Director, Global Logistics, Warehousing and Trade Compliance is responsible for defining and executing the global strategy, operational leadership, and compliant storage and movement of materials supporting R&D, Clinical, and Commercial programs across Beam. This role provides end‑to‑end leadership across global logistics operations, warehousing networks, and trade compliance, ensuring reliable supply, regulatory adherence, and scalable infrastructure to support pipeline growth and commercialization.

This position reports to the Vice President, Supply Chain and serves as a key member of the Supply Chain Leadership team, partnering closely with Technical Operations, Quality, R&D, Finance, Legal, Procurement, Clinical Patient Supply and Commercial Patient Operations.

Responsibilities:

• Global Logistics: Provides operational and strategic leadership for all R&D, Clinical, and Commercial shipments. Serves as subject matter expert for ambient, low‑temperature, and ultra‑low‑temperature cold chain systems, including shipping systems qualification and lane validation, in support of CMC development and commercialization. Supports Commercial Patient Operations for Risto-cel Patient shipments.
• Warehousing: Leads internal warehouse operations and the global 3PL network supporting storage, inventory management, kitting, and production support for critical raw materials, drug substance, and drug product. Ensures inventory accuracy, material availability, and scalable warehouse capabilities aligned with clinical and commercial demand.
• Trade Compliance: Acts as the enterprise risk leader for global trade compliance, ensuring compliance with international, federal, and state import/export laws and regulations. Leads the development and governance of compliant, efficient trade processes across North America, Europe, and Asia‑Pacific regions, and serves as the primary interface with customs brokers, government agencies, and external auditors. Champions a culture of compliance while enabling business agility and uninterrupted supply. Supports Market Access team for any commercial trade or channel distribution aspects.
• Strategy & Leadership:
  • Develop and execute global logistics, warehousing, and trade compliance strategy to support R&D, clinical trials, and commercial operations.
  • Establish long‑term vision for a flexible, scalable global distribution and storage network, aligned with Beam’s growth and commercialization plans.
  • Serve as a senior leader influencing enterprise and site‑level supply chain strategies, including readiness for new product launches and expansion of cell and gene therapy programs.
  • Build, lead, and develop high‑performing teams, fostering a strong talent pipeline, culture of accountability, and continuous improvement mindset.
• Logistics Operations
  • Provide operational leadership for global distribution, including domestic and international shipments from internal sites and external partners.
  • Lead shipping operations supporting R&D, clinical, and commercial programs, ensuring on‑time, in‑full delivery and patient‑centric execution.
  • Own cold chain strategy and execution, including qualification, validation, monitoring, and continuous improvement of shipping lanes and systems.
  • Ensure logistics operations comply with GMP, GDP, EHS, product security, and data integrity requirements.

• Warehousing & Inventory Management:
  • Lead internal and external warehousing operations, including inventory control, materials management, kitting, and production support.
  • Ensure no disruption to production schedules while proactively identifying and mitigating supply risks.
  • Drive inventory optimization, accuracy, and visibility across the network using ERP and digital tools.

• Trade Compliance & Governance
  • Create, lead, and chair the Trade Compliance Committee, ensuring adherence to all applicable global import/export laws, regulations, and guidance.
  • Develop and maintain a robust global import/export compliance framework, including permits, licenses, valuation, duties, VAT, sanctions, HTS classification, country of origin, and applicable Tariffs/Free trade agreements.
  • Serve as primary respondent to regulatory agency inquiries; investigate issues, develop corrective strategies, and ensure timely, compliant responses.
  • Lead duty savings and optimization strategies in collaboration with Finance and Supply Chain, while maintaining full regulatory compliance.

• Performance, Financial & Operational Excellence
  • Establish and monitor KPIs across logistics, warehousing, and trade compliance with clear, data‑driven reporting.
  • Manage operating budgets, capital expenditures, and cost optimization initiatives.
  • Drive automation, digitalization, and process improvements to enhance efficiency, scalability, and compliance.
  • Champion lean principles, continuous improvement, and right‑first‑time execution across the organization.

• Stakeholder & External Engagement
  • Build and maintain strong partnerships with Legal, Finance, Clinical, Commercial, Quality, Manufacturing, Procurement, IT, and HR.
  • Represent the company with customs authorities, regulatory agencies, industry groups, and external counsel as required.
  • Participate in global forums to influence policy, standardization, and best practices across the supply chain network.

Qualifications:

• Bachelor’s degree in Business, Supply Chain, Engineering, Life Sciences, or related field; MBA or Master’s degree preferred.
• 18+ years of progressive experience in global logistics, warehousing, supply chain, and/or trade compliance within biotech, pharmaceutical, or other highly regulated environments.
• Proven senior leadership experience managing complex global networks of internal operations and external partners (CMOs, CDMOs, 3PLs).
• Working knowledge of global trade compliance regulations, including U.S. Customs and relevant international authorities; experience with permits, licenses, duties, VAT, sanctions, and duty savings strategies.
• Demonstrated expertise in pharmaceutical cold chain logistics (ambient, refrigerated, frozen, ultra-low temperature) across R&D, clinical, and commercial programs.
• Strong strategic and operational leadership skills, with the ability to influence cross-functional and matrixed stakeholders globally.
• Excellent analytical, communication, and decision-making skills in high-complexity environments.
• Financial acumen including budgeting, cost control, and KPI management.
• Experience with ERP systems (SAP preferred) and electronic Quality Management Systems.
• Relevant certifications or formal trade compliance training are preferred (e.g., Customs, Export Compliance, APICS, HAZMAT).

Travel / On-site Requirements:

Up to 20% travel required to support internal sites, external partners, and global supply chain initiatives.

Onsite requirements: Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.