Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
Post: Team Member - Process Development
Job Number: R&D PDL_Team Member - Process Development
Job Description:
Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit mylanlabs.in
Areas of Responsibility
The Team Member - Process Development will have the following key responsibilities:
1) Technical discussion with responsible formulation and development Personnel about process in trial and exhibit batches for ANDA products.
2) To execute and evaluate the lab scale up, Pilot batches, Pre- exhibit batches and the exhibit batches.
3) Troubleshooting during execution of trial, exhibit and validation batches.
4) Review of site transfer dossier and developing site transfer products, raw material procurement for trial and validation batches.
5) Coordination with Production department/QC/QA for the execution of exhibit batches and validation batches.
6) Coordination with Analytical development team for getting analytical data with respect to the trial, Exhibit batches. Evaluation of the analytical data and firming of the strategy.
7) Providing product specific information to Production and packaging development team with respect to procurement of equipment and change parts.
8) Documentation w.r.t justifications, investigation reports, Validation protocols and reports, Batch manufacturing records of feasibility batches etc.
Qualifications
Bachelor in Pharmacy/ Masters in Pharmacy
Experience:
FDF: Minimum 1 year of experience in reputed companies with exposure in regulated markets.
Competencies:
- Formulations/ process knowledge
- Knowledge of manufacturing equipment and processes
- EHS knowledge
- Knowledge of SOPs
Additional Information:
Experience: min. 1 years
Location: Nashik, Aurangabad
Education: B.Pharm, M.Pharm
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Process Development
End Date: 21st Dec, 2012
Requisition ID: 12000673
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