Apply to the Jobposition - Technical Expert Derma / Topical products
Position Details |
Position: |
Technical Expert Derma / Topical products |
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Generics |
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Middle Management |
Location : |
Hyderabad |
Unit : |
Integrated Product Development Organization (IPDO) |
Expiry Date : |
Monday, February 28, 2011 |
Academic Background and Key Experience Requirements :
• M. Pharma/Ph.D Organic Chemistry
• 5-8 years of Relevant experience in formulations development of Modified Release, Delayed Release, Controlled Release
• Good Work Experience in Semi Solid / Topical products
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Roles and Responsibilities :
• Review the literature and coordinate with IPM
• Prioritize development of the formulation depending on urgency
• Look at the patent landscape and the manufacturability of the product
• Finalize the synthetic scheme of experiments
• Plan and allocate resource as per project priorities within the team and assess the cost impact
• Ensure compatibility between API and excipients
• Review input document/interim reports
• Prepare the reports after conducting various studies (like stability study and bioequivalence study) at every stage of the formulations development
• Ensure proper compilation of results from pivotal studies, to be sent to regulatory authority
• Prepare specifications for the raw materials and finished goods
• Prepares the calibration schedule of the various instruments and ensure that it is followed properly in the lab
• Prepare guidelines and SOPs as and when required and ensure that the team members work according to the SOPs, GMP and GLP
• Ensure proper coordination with the team members from Analytical R&D department
• Provide necessary support to the team members for risk assessment and mitigation
• Train the team members in specific areas
• Ensure proper maintenance of Lab notebooks
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Key Performance Indicators :
• Number of Products developed on time
• 20 ANDA
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Key Personal Attributes :
• Should have a good understanding of working of the R&D equipments
• Should be able to analyze the data generated during process development and interpret them
• He should be well aware of the SOPs, GMP and the safety norms to be followed in the labs
• Should be good at interpersonal and leadership skills
• Should be able to manage the performance of his team well
• He should have good communication skills
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Operating Network :
• Interact with PDT members, COEs and Regulatory Authority
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