Leadership Role, Process Control Strategies Biologics

Company Name:
Newly created director-level role in Metrowest, Massachusetts at an international company with several products on the market and a large global presence. As part of the global MTS group, you will lead critical technology transfer projects and global technology projects.
The main function of this role is to further develop a technical/scientific philosophy and shared vision for drug substance process control strategy for new and legacy products.
Responsibilities include but are not limited to;
o Implement philosophies, policies and procedures to improve process and product understanding, reduce process variability, increase operational flexibility, improve yields/throughput, and reduce costs.
o Creating objective approaches and develop objective tools for identifying and assessing critical quality attributes (CQA) and critical control parameters (CPP). Driving value from better understanding of the inter-relationship between Quality Target Product Profile, CQA's and CPP's.
o Leverage improved process and product understanding to enhance approaches to process validation and post-approval process-related lifecycle management
A formal description can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher in Chemical Engineering or a relevant field. The Hiring Manager can consider candidates from upstream, downstream or analytical development backgrounds, given they have the requisite experience in drug substance process control strategy.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Metrowest, Massachusetts area or able to relocate with limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

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