Our client, a commercial-stage biopharmaceutical company is seeking a senior process engineer to lead Commercial and Clinical manufacturing process Trending and Performance Efforts. In this role you will lead a cross functional team in order to assess and develop a lifecycle plan to improve manufacturing costs and efficiencies, while maintaining appropriate product quality. This position is highly analytical and will support strategic and tactical elements of a new continuous improvement culture across our client's Technical Operations scope. This role will support ongoing manufacturing performance, while introducing mid and long range performance opportunities to our client's manufacturing process.
The ideal candidate will be highly organized with key competencies in manufacturing process analysis and can lead both internal as well as external manufacturing improvement efforts. Subject matter expertise, highly effective interpersonal leadership skills, and a high degree of passion will be required to be successful. You will report to the Head of Process Technology and also will be a core part of the technical operations mandate of delivering a best in class operation to serve our client's patients and their families.
Responsibilities will include
- Establish Robust Process Performance Metrics and Trending Procedures Across Commercial Manufacturing to aid Process Optimization and Lifecycle Management Efforts
- Collaborate with Quality and Supply Chain to support ongoing manufacturing performance
- Supporting Type 2-4 Investigations, OOS, OOT's and Process Performance Initiatives
- Support Process Modeling, Sensitivity Analysis and Control Strategy for Clinical and Commercial Products to identify and help prioritize lifecycle opportunities
- Support Development Efforts to improve process performance and efficiencies.
- PAS Support
- Technical Operations including Process Development, Manufacturing, Supply Chain, Technical Support, Quality. Commercial and clinical product/CMC operations.
- Process Engineer, Chemical Engineer
- 5-10 years Commercial Manufacturing Experience
- Strong Analytical Competency, including process trending and modelling
- Strong Pilot Plant or Hands on Process Engineering experience to lead development projects both internally and through our client's external collaboration