MSTG Scientist II

Job Summary

Scientist II, MSTG, performs process development studies, Exhibit batch and process qualification activities.  This position also prepares technical documentation to support development and validation program at Sun Pharma.  This position provides technical support to Manufacturing and Quality department.

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.

Work Conditions:

Corporate Office Environment located in a Manufacturing/Production and Warehouse Facility.

Environmental related to manufacturing/production environments:

• 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.

Physical Requirements:

• 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.

Travel Estimate

Up to   10  %

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.
• 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 desirable.