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Lead Scientist, MSTG
3 months ago
Job Title:
Senior Scientist, MSTG
Overview:
The Senior Scientist, MSTG is responsible for conducting process development research, overseeing exhibit batch production, and managing process qualification initiatives. This role involves the creation of technical documentation to support the development and validation processes at Sun Pharma. Additionally, the position offers technical assistance to the Manufacturing and Quality Assurance departments.
Required Experience:
A minimum of eight years in the field is essential, with a preference for experience in the development of solid oral dosage forms.
Key Responsibilities:
- Design and implement Design of Experiments (DOE), process optimization trials, and qualification batches, along with compiling and analyzing process data using statistical methodologies.
- Develop comprehensive documentation packages that encompass all phases of product development, including process studies, characterization, qualification, and cleaning validation.
- Maintain a thorough understanding of manufacturing technologies and equipment utilized in solid oral dosage production.
- Prepare Master Batch Records, Exhibit Batch protocols, and all necessary pre-validation and validation documentation and reports.
- Provide troubleshooting support for manufacturing operations, completing assigned projects with minimal oversight.
- Lead compliance investigations, corrective actions (CAPA), and change control processes.
- Collaborate with cross-functional teams to address specific challenges, facilitate discussions, and enhance procedural efficiency while fostering interdepartmental relationships.
Work Environment:
- Work conditions are typical of manufacturing and production settings, which may include:
- Moderate noise levels that could distract or impair hearing.
- Exposure to fumes and vapors resulting from chemical reactions.
- Potential unpleasant odors.
- Presence of gases such as carbon monoxide and ozone.
- Physical demands may include frequent lifting or moving of lightweight materials up to 10 lbs.
- Ability to navigate both office and plant environments, including standing, walking, and reaching.
- Requirement to wear appropriate personal protective equipment, including respirators, safety glasses, and safety footwear.
Qualifications/Education:
- A minimum of a Bachelor’s degree in a relevant scientific discipline, such as Pharmacy, Pharmaceutical Sciences, or Chemical Engineering; a Master’s degree is preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, Project, PowerPoint).
- Strong organizational skills and attention to detail.
- Excellent analytical, problem-solving, and decision-making abilities.
- Effective verbal and written communication skills.
- A proactive, hands-on approach with a positive attitude.
- English language proficiency at an Intermediate-B1+ level, as defined by the Common European Framework of Reference for Languages (CEFR).
The compensation and benefits package is subject to the terms and conditions of governing plans and policies. Employees may participate in various benefit programs, including medical, dental, and vision coverage, life and disability insurance, retirement savings plans, and paid time off.
EEO Statement:
Sun Pharma is committed to providing equal employment opportunities to all employees and applicants, ensuring that no individual is discriminated against based on race, religion, gender, age, disability, or any other legally protected status.
Agency Notice:
Sun Pharmaceuticals does not accept unsolicited resumes from agencies or search firms for this position. Any resumes submitted without a valid agreement will become the property of Sun Pharma, and no fees will be paid for unsolicited referrals.
