Principal Scientist, MS&T
2 weeks ago
Catalent is a global pharmaceutical company seeking a highly skilled Principal Scientist, MS&T to join our team. As a key member of our Manufacturing Sciences and Technology (MS&T) department, you will be responsible for the technical transfer of processes from Process Development or our clients. This role will also involve drafting and review of documentation, compilation, and assessment of process data, and providing technical input for deviation investigations, change controls, and CAPAs.
Key Responsibilities:
- Perform as a subject matter expert (SME) for multiple Drug Substance operations (e.g., Upstream Processes (seed train, production bioreactor processes), Downstream Processes (chromatography, tangential flow filtration, etc.), Formulations)
- Utilize Process Development and client provided process data to review proposed GMP scale process descriptions. Create process flow diagrams from process descriptions
- Lead efforts associated with the evaluation, alignment, and recommendation of equipment and process improvements
- Review daily processing data from GMP manufacturing to monitor process performance and anticipate performance in subsequent steps; work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing
- Evaluate existing processes and implement process or equipment improvements to advance efficiency, consistency, and competitiveness within the market
- Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification
- Responsible for motivating, coaching, and developing coworkers as a subject matter expert; act as a mentor to lower-level team members and Co-ops/interns
- Bachelor's degree in Science and 7+ years of pharmaceutical industry experience, required
- Master's degree in Science and 5+ years of pharmaceutical industry experience, preferred
- 5 years GMP or regulated industry experience, required
- Must be able to read and understand English-written job instructions and safety requirements
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
- Meaningful work in a dynamic, fast-paced environment
- Opportunities for professional growth and development
- Competitive compensation and benefits package
- Collaborative and inclusive work environment
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