OVERVIEW OF ANDELYN BIOSCIENCES

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

The GMP Quality Control (QC) Scientist I will perform assigned tasks to support the daily operations of the GMP QC laboratory. The primary objective is to ensure that all activities within the GMP QC laboratory facility comply with the requisite regulations (21 CFR Part 211 Subpart I, 21 CFR Part 11, et. al.). Working in close collaboration with QC Management, and senior QC staff the Scientist I will aid all day-to-day lab operations, including project and timeline management, materials management, assisting with laboratory investigations, SOP generation and revision, and assay performance. The Scientist I will aid QC Management in ensuring that their assigned tasks are performed by following appropriate regulatory practices, analytical methods, and Standard Operating Procedures (SOPs) for GMP.

• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Works in close collaboration with the QC Management and senior QC staff to cultivate and enact strategic direction of the GMP area including determination of schedule and project timelines/capabilities
• Provides QC Management with all laboratory data generated from QC laboratory tasks, including in-process, release, and stability testing. Manages and reviews the compilation of all data and ensures its correctness
• Assists in shipment and communications with all external QC laboratory activities in coordination with QC Supervisor
• Assists QC Management with the management of laboratory investigations, the QC portion of deviation investigations, OOS results, process change controls, and required process SOP revision and remediation
• Works in close collaboration with the QC Management and senior QC staff to ensure continuous improvement objectives are identified and met using metrics and other statistical means
• Works in close collaboration with the QC Management and senior QC staff to ensure new projects and technologies are sought for incorporation into the GMP area
• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Identifies problems and performs tasks as assigned
• Work under the general supervision of senior staff and leadership
• Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of the team and goals
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Nominal fiscal responsibility
• Other duties as assigned