The Quality Control (QC) Specialist III will support QC testing requirements of cell-based therapeutics destined for human clinical trials, from starting materials to final differentiated cell therapy.  The QC Specialist will ensure QC Test methods are executed in a GMP compliant manner for samples generated by Manufacturing, including Raw Materials, Intermediates, Final Drug Product and through to Doses prepared for the clinic. Duties will include writing and reviewing Standard Operating Procedures (SOPs) related to QC functions, writing and reviewing SOPs and documents related to QC functions, supporting deviation/OOS investigations, training and mentoring team members.

Responsibilities:

• Perform and/or support QC testing activities for release testing of raw materials, cell lines, process intermediates, drug products and other materials.
• Collaborate with internal/external/ cross-functional teams to ensure the timely and compliant progression of QC testing and release of cGMP cell banks.
• Write, review and drive approval of SOPs related to quality control testing including test methods, and equipment operation and maintenance procedures.
• Execute and/or coordinate QC testing activities for stability, comparability, and investigational studies, as needed.
• Supporting the deviations/OOS investigation procedure as it relates to QC testing activities and facilitate implementation of phase appropriate CAPA and change controls to drive continuous improvement, including protocol generation, execution and report writing.
• Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies.
• Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory, and reagent preparation.
• Support technical training and mentoring of team members.
• Other duties as required.

Minimum Requirements:

• BSc in Life Sciences with minimum 6 years relevant experience in Cell Biology, Genetics, Biotechnology, Biochemistry or related field or MSc with minimum 4-year or PhD with 0+ years’ relevant experience.
• Strong preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment.
• Experience in flow cytometry is required.
• Experience in one or more of the following techniques preferred: qPCR, ddPCR, mammalian pluripotent stem cell culture, fluorescence microscopy, high throughput imaging, next generation sequencing.
• Experience in gene-editing strategies and cell line characterization is highly desirable.
• Excellent written and oral communication skills, with keen attention to detail and highly organized. 
• Demonstrated flexibility in adjusting to changing priorities and schedules.
• Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus.
• Occasional weekend work on an as needed basis may be required.

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