Manufacturing Sciences Associate
4 weeks ago
Sun Pharma is seeking a highly skilled Manufacturing Sciences Associate to support process development studies and process validation activities. This role involves preparing technical documentation to support development and validation programs, as well as providing technical support to the Manufacturing and Quality departments.
Key Responsibilities- Design and execute DOE's, process optimization studies, and process qualification batches.
- Compile and analyze process data using statistical tools.
- Develop a strong documentation package, including process studies, characterization, process qualification, and cleaning validation.
- Prepare Master batch records, Exhibit Batch protocols, pre-validation, and process validation documentation and reports.
- Provide troubleshooting support to manufacturing operations.
- Champion compliance investigations, commitments (CAPA), and change controls.
- Participate in cross-functional teams to address specific problems, facilitate discussion, and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
This role is based in an office environment located within a Manufacturing/Production facility.
The work environment is related to manufacturing/production environments, with potential exposure to:
- Noise: Sufficient noise to cause distraction or possible injury to 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.
- Hazards: Conditions where there is danger to life, health, or bodily injury, such as closeness to moving mechanical parts, working on scaffolding and high places, exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.
- 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.
Up to 10% travel is required for this role.
Education and Job Qualification- Minimum B.S. in a relevant science field, such as Pharmacy, Pharmaceutical Sciences, Chemical Engineering, or related disciplines. M.S. preferred.
- Proficient in MS office applications (Word, Excel, Projects, PowerPoint).
- Good interpersonal, oral communication, and technical report writing skills.
- Analytical thinking and problem-solving skills.
- A self-starter with a hands-on approach and a can-do attitude.
- Intermediate-B1+ level English language proficiency, comparable to Global CEFR Independent B1.
- Minimum one year of industry experience, ideally with solid oral dosage development.
- Process qualification, process validation, and cleaning validation experience considered.
- Master's degree considered in lieu of experience.
Sun Pharma is an equal employment opportunity employer and welcomes applications from diverse candidates. We provide a comprehensive benefits package and opportunities for professional growth and development.
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