QC Manager, Analytical Methods

4 weeks ago

Durham, United States Beam Therapeutics Inc. Full time
Position Overview:

Beam is seeking a highly talented and motivated QC Manager to join our growing analytical team. The Quality Control Manager, Analytical Methods will be responsible for overseeing in-process analytical testing to support critical cGMP manufacturing operations across multiple programs. The QC Manager will also help drive critical analytical method implementation workstreams in support of program start-up and scale up including hiring, oversight of instrument qualifications, analyst training, and oversight of technical protocols for method qualification and validation.

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

Responsibilities:
  • Provide technical oversight for QC analysts during execution of in-process analytical methods to ensure safety, compliance, efficiency, and sustainability of cGMP testing.
  • Manage and actively participate in laboratory operations including routine instrument calibrations and maintenance, inventory management and assay trending.
  • Ability to motivate, lead and develop QC Analyst and Senior Analysts as direct reports.
  • Application of quick problem-solving, troubleshooting, and decision-making skills required for in-process testing and reporting of critical results to manufacturing team.
  • Ensuring GMP compliance with applicable procedures and testing requirements.
  • Real time review of data sheets and approval of results in LIMS.
  • Immediate communication and escalation of significant issues to management for any quality issues encountered during testing that may impact patient safety or product quality.
  • Author deviations and change controls, lead deviation investigations, drive process improvements and develop CAPAs.
  • Partner with other functional areas for program start-up activities, ongoing continuous improvement to support current testing and future scale-up as well as for problem resolution.
  • Author technical documents including test methods, protocols, and reports.
Qualifications:
  • Bachelors in a scientific discipline with 8+ years' experience in the pharmaceutical/biotech industry.
  • 2+ years of previous management experience in a GxP environment is preferred.
  • Knowledge of and/or hands-on experience with various analytical methods including assay development, qualification/validation, and/or routine sample testing is required.
  • Experience with flow cytometry testing and data analysis is preferred.
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
  • Strong team player that has a customer service approach and is solution oriented.
  • Ability to work in a high-paced team environment, meet deadlines, and prioritize tasks across multiple projects.
  • Excellent listening, communication and interpersonal skills fostering team spirit.
  • Ability to support 2nd shift schedule to oversee QC in-process testing to support Manufacturing operations.

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