Purpose

Scientist I in the biologics pilot lab plays a key role in cell culture scale-up development, with additional opportunities to support purification scale-up activities. Responsibilities include delivering first-in-human (FIH) programs on accelerated EBE timelines, supporting technical transfers of in-licensed and acquired assets to manufacturing, and driving technological innovation. The role also focuses on fostering collaboration within the team and cross-functionally to advance project goals, optimize workflows, and ensure safety and compliance standards are upheld.

Responsibilities

• Lead scale-up development for assigned projects cell culture activities within the pilot lab, supporting early biologics development.

•Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.

•Identify, evaluated, and support innovative technology implementation into GMP manufacturing

•Collaborate cross-functionally with analytical, upstream, downstream, cell line development, project management, and manufacturing teams to support project objectives and timelines

•Provide technical expertise in cell culture process development, optimization, and troubleshooting of pilot lab unit operations from vial thaw, through cell expansion, wave bioreactors, 50-500L single use production bioreactors, and centrifugation operations.

•Analyze, interpret, and present experimental data to stakeholders and management.

•Contribute to technical reports and regulatory documentation as needed.

•Drive innovation and continuous improvement in cell culture techniques, workflows, and equipment.

•Oversee daily laboratory operations, ensuring efficient workflow, safety, and compliance with applicable regulations and standards.

•Maintain accurate documentation of processes, experiments, and results in accordance with company and regulatory requirements.