Senior Specialist I​/II, Analytical Instrument and Systems Qualification

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:

The Quality Control (QC) Specialist I/II-Analytical Instrument Qualification is responsible for the end‑to‑end onboarding, qualification, and lifecycle management of analytical instruments used in both Massachusetts and North Carolina GMP testing laboratories. The role authors and/or reviews core validation deliverables (URS, SIA, DIAS, CS, FDS), plans and executes risk‑based qualification (IQ/OQ/IOQ/PQ), maintains traceability, and ensures assets remain in a validated state through structured change control and periodic validation maintenance.

Work is executed in accordance with internal procedures and associated work instructions/templates in Beam 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/or execute change controls for instrument configuration changes, software upgrades, relocations, and method impacts; perform impact assessments and define re‑qualification needs.

* Perform/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…