Position Overview:

Beam is seeking a highly motivated and energetic Analyst to join our growing QC analytical team.  The Senior Quality Control Analyst will be responsible for performing various analytical methods to evaluate the quality of critical in-process samples to support cGMP manufacturing operations across multiple site programs. This role will also be responsible for daily laboratory operations including reagent receipt and inventory management and equipment maintenance. This position will support deviation initiation and investigations as well as implementation of continuous improvements. The Analyst will support critical analytical method implementation workstreams in support of program start-up and scale up.

This role will work closely with team members in Quality Assurance, Manufacturing, MS&T and Analytical Development.  The position will report to the Senior QC Manager. The Analyst I is expected to be an on-site resource at Beam’s manufacturing facility in RTP, North Carolina to support project start-up and routine clinical and commercial operations.

Responsibilities:

• Cultivate Beam’s culture and our values-driven organization focused on people.
• Execute against the mission, vision, and strategy for Beam internal Quality organization.
• Ensure safety, compliance, efficiency, and sustainability throughout cGMP testing.
• Execution of in-process analytical methods including flow cytometry, cell blood count, cell count and viability, HPLC, and plate-based ELISAs.

• Real time documentation within data sheets and LIMS following appropriate test methods, SOPs and ALCOA+ principles.
• Responsible for daily and weekly lab tasks to maintain general upkeep of the laboratory such as room cleaning and inventory management.
• Perform QC laboratory instrument maintenance including cleaning, calibration and supporting preventative maintenance according to pre-established maintenance schedules.

• Analyze and interpret data within given parameters; escalate unexpected results to area manager and provide support for deviation initiation, investigation and CAPAs.
• Tracking, ordering, and stocking of laboratory reagents and materials.
• Clearly and concisely communicate complex issues to peers, manager and to other cross-functional teams.

Qualifications:

• Bachelor’s degree required, preferably in a chemistry, life science, or related discipline.
• 1 - 3 years (Analyst) / 5+ years (Sr. Analyst) relevant bioanalytical assay experience including flow cytometry and/or ELISA methods.
• Prior GMP experience is preferred.
• Advanced technical writing skills and problem-solving ability.
• Ability to work 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 different functional groups.
• Ability to support 2^nd shift schedule to oversee QC in-process testing to support Manufacturing operations.