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Post: Associate Director – Formulation Development
No.of post: 01
Job Description
• Control the functional and administrative activities of Galenic Lab.co-ordinate tech transfer to pilot plant/ manufacturing sites.
• Provide inputs to prepare timelines and cost of development for products to be developed.
• Provide Technical inputs for development of new products to support generics base business (Intercontinental and Asia Pacific) and local (Indian) marketing teams and for compilation of CMC part of Dossier for registration of new products.
• Design and implement documentation systems for formulation development to support quality function.
• Interact with Identified vendors of APIs for identified products.
• Monitor progress of development and pilot batch manufacturing activities of the identified projects.
• Provide technical expertise to groups sites at Goa and Ankleshwar as well as to contract manufacturing sites product transfers, process troubleshooting, optimization and robustness, process validation, yield improvement and reduction of COGM in order to enhance the performance of IA in India.
• Liase with Project Management, Materials Management, Analytical Development, Regulatory and other functionary areas to meet project and team objectives.
• Lead /Participate in problem solving for formulations, equipment’s and processes Prepare Development plans for Associate and Implement HR processes like Priorities setting, IVR,APP, People Development
Other Info:
• Designing of Experiments for trouble shooting
• Decision on the vendors for actives / Inactive approval based and stability study results.
• Decide upon optimization of process parameters during manufacturing of products.
• Work team includes all the executives in formulation development, analytical development and Regulatory affairs
• Budget and operational revenue expenses
• Prepare timelines, cost estimates and resource requirement for development of new formulation.
Candidate Profile
• 10 to 15 years of cross functional experience in Formulation Development and Manufacturing of pharmaceutical dosage forms.
• Managing group scientists to achieve organizational objectives.
• Core competencies-generic product development for regulated markets.
• Design and implement various documentation and quality systems for formulation Development.
• Design experiments for development of oral solid dosage forms.
• Development of formulation from API sourcing though formulation studies, lab scale development trials to pilot batch manufacturing and technology transfer to manufacturing premises.
• Process development and validation and stability studies.
• Operational knowledge of equipment’s for manufacture of Tablets and capsules.
• Current regulatory requirements drug product marketing authorization and variations.
• Project Management
• Conception, Analytical and Problem solving skills.
• Effective communication and Administration Skills
Additional Information:
Experience: 12-22 years
Qualification: M.Pharm
Industry Type: Pharma
Job Type: Formulation development
Salary: 30 to 45 lakhs per annum
Location: Goa & Mumbai
Last Date: 5th April, 2016
Send your CV to easyreachhr@gmail.com
Posted by,
Suvidnya Tendolkar,
Easy Reach Management Consultants
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