Senior Specialist I/II, Analytical Instrument and Systems Qualification

Описание вакансии

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 with integrated gene editing, delivery and 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 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:

Beam is looking for a highly motivated Senior Specialist I/II, Analytical Instrument and Systems Qualification to join our growing Quality Control team. The Senior Specialist I/II, Analytical Instrument Qualification will be responsible for the end‑to‑end onboarding, qualification, and lifecycle management of analytical instruments used in both Beam's Massachusetts and North Carolina GMP testing laboratories. This role will author and/or review core validation deliverables (URS, SIA, DIAS, CS, FDS), plan and execute risk‑based qualification (IQ/OQ/IOQ/PQ), maintain traceability, and ensure assets remain in a validated state through structured change control and periodic validation maintenance. Work will be executed in accordance with internal procedures and associated work instructions/templates in Beam's Quality Management System with specific attention to embedded software/data integrity expectations.

Primary Responsibilities:

• Lead or support onboarding of new analytical instruments, defining system boundaries, intended use, and qualification strategy in alignment with SIA and URS, including Draft, review, and secure approval of URS, SIA, DIAS, CS, and FDS deliverables.
• Author and execute IQ/OQ/IOQ/PQ protocols (as appropriate), ensuring test pre‑requisites, evidence, and deviations are documented and resolved prior to release for GMP use.
• Build and maintain the Requirements Traceability Matrix (RTM) to link requirements (URS/DIAS/CS/FDS) through protocol test cases and results; compile a Qualification Summary Report (QSR) to close projects.
• Define and verify data integrity and computerized system controls per DIAS (e.g., access management, audit trails, e‑records/e‑signatures, backup/recovery, calculations, data flows/interfaces) for instruments with embedded or attached control software.
• Initiate and execute change controls for instrument configuration changes, software upgrades, relocations, and method impacts; perform impact assessments and define re‑qualification needs.
• Perform and participate in periodic validation maintenance reviews to confirm lifecycle documents (SIA, URS, DIAS, CS, FDS, RTM, QSR) remain current and that assets stay in a validated state.
• Partner with QC SMEs, Digital Quality & Data Integrity, Validation, QA, IT, Facilities/Metrology, and vendors to plan and deliver qualification on schedule; coordinate service/vendor activities for installation, calibration, and PM in support of qualification and sustainment.
• Support internal/external audits and health authority inspections as the qualification/validation point of contact for assigned instruments, providing rationales, traceability, and documented evidence.
• Lead or support investigations and CAPAs related to instrument performance, data integrity, or qualification gaps, ensuring timely closure and documented effectiveness checks.

Qualifications:

• Bachelor’s or Master’s degree required, preferably in a life science discipline with 10-12 years’ experience.
• Working understanding of various analytical techniques primarily flow cytometry, plate based assays, automated liquid handling, liquid chromatography, capillary electrophoresis, and next generation sequencing.
• Experience qualifying and sustaining a range of QC instruments (e.g., HPLC/UPLC, GC, CE, UV‑Vis, FTIR, TOC, qPCR/plate readers, balances, pH meters, osmometers, NGS, Flow Cytometers), including networked data systems and interfaces.
• Working knowledge of applicable regulatory expectations for e‑records/e‑signatures and computer systems (e.g., Part 11/Annex 11), with successful inspection support.
• Experience collaborating across multi‑site QC organizations and with equipment vendors to deliver validation to plan. Technical writing skills.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.
• Documentation Excellence: Clear, complete, and audit‑ready authorship of URS, SIA, DIAS, CS, FDS, protocols, RTM, and QSR.
• Systems Thinking: Ability to define system boundaries, dependencies, and data flows; translate requirements into testable specifications and traceability.
• Quality Mindset: Applies risk‑based, phase‑appropriate validation; maintains validated state through disciplined change control and periodic review.
• Collaboration & Influence: Works effectively with QA/Validation/IT/Digital Quality & Data Integrity, lab users, and vendors to resolve issues and meet milestones.
• 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.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range

$140,000—$185,000 USD