MSTG Scientist II

Description

• 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.

Qualifications

• 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.
• 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).

Experience

• Minimum six (6) years of experience in solid oral dosage development is preferred .