Manager CHC Formulation and Process Development - United States
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Major Responsibilities are:
- Lead product/process development and commercialization activities (as either an individual contributor or technical leader of junior level scientists) for new immediate release and modified release solid oral dosage forms interfacing with Analytical Research & Development scientists to facilitate “First-to-File” and “First-to-Market” corporate goals.
- Lead the manufacture of Pivotal/Registration lots for new products in the Formulation/Process Development Pilot Plant and Manufacturing facilities.
- May supervise and mentor team of junior level scientists and technicians in the design and execution of product development activities.
- Design and perform quality scientific experimentation to develop robust processes in support of Product Development activities.
- Contribute to the development of new experimental approaches using Quality by Design approaches.
- Design and conduct stability studies. Analyze and defend scientific results from experiments.
- Generate accurate, reliable data by following established procedures and practices to support product development.
- Record, tabulate, summarize, interpret, report and publish results.
- Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale up and process confirmation batches.
- Maintain scientific currency. Acts as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provides technical support to Technical Operations, Manufacturing, Quality and Regulatory Affairs.
- Interacts with regulatory agencies, as needed basis.
- Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope Formulation/process development and improvement projects.
- Communicates effectively to project manager and the wider development team and presents data at team meetings and departmental technical meetings.
- Leads and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits.
- Ensure compliance with current Good Manufacturing Practices (CGMP), company policies and Quality Systems, and all applicable regulatory agencies.
- Considerable breadth and depth of problem solving experience is necessary.
- Excellent communication skills and the ability to represent the department to both internal and external constituencies are required.