Process Engineer / Sr. Process Engineer
Work Location: Tevogen Lab Operations, Philadelphia, PA 19104
Division/Department: Technical Operations
Reports to: Chief Technical Officer
Position: Full-time, Exempt
Essential Duties and Responsibilities:
The Process Engineer / Sr. Process Engineer will contribute to process development and engineering support for process design and development, process characterization, and process improvements in GMP manufacturing. The primary responsibilities will be to execute and support lab studies to develop and characterize the manufacturing process for Tevogen’s allogeneic T cell therapy products. Experiments will be performed to identify and define critical process parameters and process ranges. Additionally, candidate will draft and review study plans and reports, analyze and trend process data, perform experiments, and provide technical support for engineering and process changes. Specific functions would include:
- Execute and collaborate on process design studies to support process development, optimization, characterization, and essential process improvements.
- Perform hands-on work in a cell culture lab and process training for GMP clinical production.
- Execute process development studies to develop a thorough understanding of operating and performance parameters.
- Conduct process characterization studies to define targets and proven acceptable ranges (PARs) of process parameters to enable robust cell culture expansion and manufacturing operations.
- Optimize final formulation, primary and secondary drug container systems that do not impact product critical quality attributes.
- Execute stability studies that characterize the product under process-relevant conditions and long-term storage conditions.
- Write and review technical documentation from writing technical SOPs, draft manufacturing batch records, technical reports, and summary reports.
- Conduct and participate in risk assessments to identify critical process parameters (CPPs) and guide late-stage characterization studies with the intent of establishing proven acceptable ranges (PARs).
- Be an effective communicator of ideas, experiment goals and results in both written and presentation format.
- Create slides and supporting data to communicate results to senior leadership.
- Support development studies and activities through IND filing.
- Ability to meet deadlines for developmental milestones.
- Other duties as assigned.
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