Job Description
Pupose:
Delivering value to the business by delivering product, post detailed analytical studies through effective methods and activities-
• Deliver analytical results to in defined timeframe to meet product delivery goals for I&D
• To develop analytical methods for drug substance, drug product and packaging material.
• To perform analysis of developmental batches, validation and stability batches
• To perform activities related to method transfer at site
• To carry out good documentation practices for all the analytical activities.
Core Job Responsibilities
Development
• Literature search related to the drug substance, create analytical profiles.
• Develop suitable analytical method for drug substance or drug product if not in Pharmacopoeia
• To carry out characterization of the API and conduct pre-formulation studies as planned by the formulator
• To conduct analysis of development samples as received from formulator and provide them with analytical report in the defined timeline.
Instrumentation
• To conduct calibration of allotted equipment with proper documentation and maintain the equipment in good condition. To follow the SOP of usage and document in the log books.
Stability
• To conduct analysis of stability samples and prepare stability reports.
Validation
• To validate the method developed and prepare validation report
Commercial Transfer
• Perform Lab to lab or Technology transfer of analytical method to the transferring site.
Documentation
• Prepare all documents related to Tech Pack for commercial transfer of the method.
• Maintain lab notebooks in proper condition and keep it updated at all times.
Safety
• To use PPE and follow safe practices in lab.
Candidate Profile
• M. Pharm/Ph. D.
• 5-7 yrs of relevant experience in space of analytical development
• M. Pharm/Ph. D.
• 5-7 yrs of relevant experience in space of analytical development
Additional Information
Experience : 5-7 years
Qualification : M.Pharm , Ph.D
Location : Mumbai
Industry Type : Pharma
End Date : 30th December, 2018
Experience : 5-7 years
Qualification : M.Pharm , Ph.D
Location : Mumbai
Industry Type : Pharma
End Date : 30th December, 2018
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