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Sr. Scientist, Solid Oral Manufacturing
New Brunswick, NJ US
Posted: 02/23/2023 2023-02-23 2023-04-29 Industry: Scientific Job Number: 23-00083
Sr. Scientist, MSTG is involved in the application and proper implementation of technical, quality, and scientific principals necessary to meet industry and customer requirements. Sr. Scientist, MSTG performs or supervise process development studies and process validation activities. This position also prepares or review technical documentation to support development and validation program. This position provides technical support to Manufacturing and Quality department.
- Design and supervise execution of DOE's, process optimization studies, and process qualification batches, Process data compilation and analysis using statistical tools.
- Ensure a strong documentation package developed, involving from conceptual study to various phases of product development like process study, characterization, and process qualification and cleaning validation.
- Review of Master batch records, Exhibit Batch protocols, pre-validation and process validation documentation and reports.
- Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
- Provide support and troubleshooting to manufacturing operations as well as identify process improvements and capacity constraints and design and execute projects to support corporate goals. Identify and define project and process improvement opportunities.
- Champion compliance investigations, commitments (CAPA), and change controls.
- Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
- Minimum M.S. In relevant science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines.
- Proficient in MS office applications (Word, Excel, Projects, PowerPoint).
- Basic knowledge of Statistical process control and related software is desirable.
- Demonstrated excellent communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- Must be a self-motivated, proactive team member with positive interaction with colleagues and stakeholders to ensure teamwork, work ethics and discipline.
- A team building champion driving innovative cross functional synergies.
- Excellent project management and problem solving skills.
- The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
- Minimum eight (8) years of experience in Solid oral Manufacturing or Process development.