MSTG Scientist II
- 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.
- Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
- Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
- Odors: Unpleasant smells.
- Gases: Examples include carbon monoxide and ozone.
- Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
- Moderate physical effort equal to frequent lifting or moving of lightweight materials up to 10lbs.
- Ability to navigate office and plant floor working environments, stands, ambulates, and reaches.
- Ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
- 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).
- Minimum six (6) years of experience in solid oral dosage development is preferred .
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