Senior Quality Control Analyst I, Analytical Methods

Position Overview:

Beam is seeking a highly motivated and energetic Senior Analyst to join the QC analytical team.  The Senior Quality Control Analyst, Analytical Methods will primarily support critical analytical method implementation workstreams including method qualification, validation, and transfers to enable start-up and scale-up of cGMP manufacturing operations across multiple site programs. The Senior Analyst will work collaboratively with cross-functional teams to plan and execute method qualification and validation activities to drive program advancement and support critical company milestones.

In addition to method lifecycle-focused work, this role will contribute to routine GMP testing ensuring continuity of QC support for both in-process, release and stability testing. This role will also support routine laboratory operations including reagent receipt, inventory management and equipment maintenance. This position will support change controls, deviations, investigations as well as implementation of continuous improvements.

The Senior Analyst will work closely with team members in Quality Assurance, Manufacturing, MS&T and Analytical Development.  The Senior Analyst is expected to be an on-site resource at Beam's manufacturing facility in RTP, North Carolina.

Responsibilities:

• Collaborate with cross-functional partners (Quality Assurance, Manufacturing, MS&T and Analytical Development) to support and execute strategy for analytical method lifecycle activities, ensuring alignment with program milestones and timelines.
• Lead and perform analytical method qualifications, validations, and transfers to support program startup, scale-up, and lifecycle management across multiple programs.
• Author and review validation protocols, reports, and supporting GMP documentation, ensuring accuracy, completeness, and compliance with internal procedures and regulatory expectations.
• Execute routine GMP testing to support in-process, release, and stability in accordance with approved methods, specifications, and SOPs.
• Perform a range of bioanalytical methods including flow cytometry, cell count, HPLC, plate-based ELISAs, etc.
• Document all testing activities accurately and contemporaneously in laboratory systems (e.g., LIMS, LES) and assay data sheets, ensuring adherence to ALCOA+ principles.
• Analyze and interpret data within given parameters; escalate unexpected results to area manager and provide support for deviation initiation, investigations, root cause analysis and CAPA implementation.
• Initiate and drive change control activities related to analytical methods, procedures, equipment, and systems as required.
• Maintain routine laboratory operations, including reagent receipt, inventory management, and general lab upkeep in a GMP environment.
• Perform and support QC laboratory instrument maintenance including cleaning, calibration preventative maintenance according to pre-established maintenance schedules.
• Identify and support implementation of continuous improvement opportunities to enhance analytical methods, laboratory processes, and operational efficiency.
• Communicate technical information and issues clearly to peers, supervisors, and cross-functional stakeholders to support timely decision-making.

Qualifications:

• Bachelor's degree required, preferably in biology, chemistry, life science, or related discipline.
• 6+ years relevant bioanalytical assay experience in methods such as flow cytometry, HPLC, ELISAs, etc.
• Prior GMP experience is preferred.
• Advanced technical writing skills and problem-solving ability.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize tasks across multiple projects.
• Advanced ability to communicate effectively with peers and demonstrate collaboration across multiple cross-functional groups.