Executive / Senior Executive - Formulation Development
Sun Pharmaceuticals, Inc, Indiana, PA, United States
Job Title:
Executive Formulation Development
Business Unit:
R&D1 Regulatory Affairs
Job Grade:
G12A
Location:
Vadodara
Job Description
M. Pharm with 3-4 Years of Formulation Research and development Experience of Peptides Injectables dosage form with Experience in Drug Device Combination Products would be an added advantage.
Execution of Various Pre-Formulation, Compatibility, Hold Time & Stability Studies.
Experience in technology transfer activities to plants Scale-up & Exhibit batches Troubleshooting & Technology transfer Documentation i.e. Master Formula Record, Stability Protocol & Development Protocol & Reports.
Preparation of Regulatory Filling Documents (Strategy document, Product Development Report, Nitrosamine, Elemental & Extractable Risk Assessment reports etc.) for advance regulated market of Peptides products
Understanding about regulatory requirements of Peptides Injectables dosage form i.e FDA, EU, Canada, Brazil. Russia & Australia
Job Requirements
Educational Qualification:
M.Pharm
Experience:
Tenure: 2 - 5 years of relevant experience
Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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Executive Formulation Development
Business Unit:
R&D1 Regulatory Affairs
Job Grade:
G12A
Location:
Vadodara
Job Description
M. Pharm with 3-4 Years of Formulation Research and development Experience of Peptides Injectables dosage form with Experience in Drug Device Combination Products would be an added advantage.
Execution of Various Pre-Formulation, Compatibility, Hold Time & Stability Studies.
Experience in technology transfer activities to plants Scale-up & Exhibit batches Troubleshooting & Technology transfer Documentation i.e. Master Formula Record, Stability Protocol & Development Protocol & Reports.
Preparation of Regulatory Filling Documents (Strategy document, Product Development Report, Nitrosamine, Elemental & Extractable Risk Assessment reports etc.) for advance regulated market of Peptides products
Understanding about regulatory requirements of Peptides Injectables dosage form i.e FDA, EU, Canada, Brazil. Russia & Australia
Job Requirements
Educational Qualification:
M.Pharm
Experience:
Tenure: 2 - 5 years of relevant experience
Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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