Senior Scientist / Principal Scientist - Formulation R&D - United States
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- Interfacing with Analytical Research & Development scientists, Technical Operations, RA, QA to facilitate “First-to-File” and “First-to-Market” corporate goals.
- Lead the manufacture of Pivotal/Registration lots for new products in the Product/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 Formulation / Process Development activities.
- Contribute to the development of new experimental approaches. 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 validation 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 to third party contractors.
- Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/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 Drug Enforcement Administration (DEA), current Good Manufacturing Practices (cGMP), company policies and Quality Systems, and all applicable regulatory agencies.
- Knowledge of the principals and practices of pharmaceutical sciences combined with professional experience in developing and testing formulation processes in more than one dosage form or product category.
- Expert with QbD principles.
- Expert in writing parts of ANDA submission relevant to the formulation / process development.
- Sound problem solving skills and good scientific judgment are required.
- Good communication skills and the ability to work on interdisciplinary teams are required.
- Hands on small scale equipment and good understanding of large scale conventional pharmaceutical equipment is required.
- Familiarity with project management methodology is necessary.
- These skills are acquired through completion of a Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with 6 to 10 years of research experience in the pharmaceutical industry, or a Master’s degree combined with 4 to 6 years of relevant research experience, or a doctoral degree combined with up to 2 - 4 year of relevant research experience.