GMP Quality Control Specialist II - Materials

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.

Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to accelerate thedevelopmentand manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope into Reality™ through our ACCTS
ions.

A CCOUNTABLE in our actions.

C OM PASSIONATE in our thinking.

T RUST WORTHY in our communications.

S UPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTS
ions.

What you will do.

The GMP Quality Control (QC) Specialist II SM will perform assigned tasks to support the daily operations of QC Starting Materials. The primary objective is to ensure that all activities within QC Starting Materials 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 Specialist II SM will aid all day-to-day Starting Material operations, including project and timeline management, inspection and sampling of raw materials in an ISO classified clean room space, testing and release of raw materials, assisting with laboratory investigations, material release specifications, SOP generation and revision.

The Specialist II SM will aid QC Management in ensuring that their assigned tasks are performed by following appropriate regulatory practices, and Standard Operating Procedures (SOPs) for GMP.

• Operate within the Quality Management System applicable to the manufacture of cGMP material
• 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 QC Starting Materials including determination of schedule and project timelines/capabilities
• Writes and reviews the creation and maintenance of Standard Operating Procedures that affect the conduct of operations within QC Starting Materials (equipment and process SOPs) and ensures that they are written with proper scope, detail, and format to meet FDA guidance
• Provides QC Management with all laboratory data generated from QC Starting Materials tasks, including material inspection, sampling, testing, and release. Manages and reviews the compilation of all data and ensures its correctness
• Supporting the proper operation, calibration, validation, cleaning, and maintenance of QC equipment and systems including the weigh and dispense suite
• Assists in purchasing, shipment, and communications with external QC Starting Materials activities, including applicable vendors and Contract Testing Laboratories to obtain needed Documentation, i.e. COA, COC, testing results, in coordination with QC Supervisor
• Assists QC Management with the management of the laboratory investigations, QC portion of deviation investigations, OOS…