· Provide bioassay, flow cytometry and/or molecular biology analytical expertise in support of QC lab investigations. This encompasses supporting technical investigations to identify root cause and provide corrective and preventive actions, including method remediations and experimental studies at the bench.
· In accordance with established protocols and research objectives, design, plan and independently execute experimental work with a high degree of technical proficiency, contribute to data analysis and documentation, and collaborate within cross-functional teams. Contribute to the development and optimization of new and existing laboratory methods and protocols.
· Present experimental findings and progress updates to immediate team. Support the preparation of internal technical reports and presentations as appropriate.
· Support transfer of commercial methods and method validation in compliance with global regulatory requirements.
· Responsible for the stewardship of bioassay, flow cytometry and/or molecular methods in the Cell Therapy Quality organization.
· Implement method lifecycle and method maintenance programs to support bioassay, flow cytometry and/or molecular biology methods in support of cell therapy drug products.
· Author, revise, and review technical documents such as test methods, SOPs, trend reports, and/or investigation reports as appropriate.
· Lead project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts.
· Provide support in the authoring of the analytical sections of regulatory submissions, responding to health authority questions and to function as the method validation and method transfer expert during inspections as required.
· Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives. Represent the function on cross-functional project teams.
· Train and mentor others on cell biology/molecular biology/ flow cytometry techniques, methods and procedures.
· Champion and foster a positive and successful collaborative quality culture.
· Perform other tasks as assigned.