Scientist I, MSTG Manufacturing Science and Technology Group
Job Summary
Scientist I performs process development studies, Exhibit batch and process qualification activities. This position also prepares technical documentation to support development and validation program at Pharma company.
This position provides technical support to Manufacturing and Quality department.
Experience :
Minimum of four (4) years of experience. Experience in solid oral dosage development is preferred.
Area of Responsibility
- Design and execution of DOE’s, process optimization studies, and process qualification batches, Process data compilation and data analysis using statistical tools.
- Develop documentation package, involving from conceptual study to various phases of product development like process study, characterization, process qualification and cleaning validation.
- Comprehensive understanding of manufacturing technology and equipment used in solid oral manufacturing.
- Responsibility for preparation of Master batch records, Exhibit Batch protocols, pre-validation and process validation documentation and reports.
- Provide troubleshooting support to manufacturing operations. Complete the assigned projects with minimal supervision.
- 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.
Education and Job Qualification
- Minimum B.S. In relevant science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines. M.S. Preferred.
- Proficient in MS Office (Word, Excel, Projects, PowerPoint).
- Organizational and recordkeeping skills.
- Strong analytical thinking, problem solving skills and decision making skills.
- Strong communication (verbal and written) skills.
- A self-starter with a hands-on approach and a can-do attitude.
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