Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: PRINCIPAL SCIENTIST - Analytical - HC/JC/2391/2013
1. Proficient in development, validation of analytical methods by various instrumental techniques to support the formulation product developments for regulatory dossier submissions.
2. Implementation of QbD principles and tools to analytical methods for entire product life cycle.
3. To handle the analytical development for various dosage forms like solid orals, parenteral, liquid formulations.
4. To handle procurement, installation & qualification of analytical equipment to set up and maintain a GLP compliant analytical testing lab.
5. Expertise in preparation of SOPs, IOPs, IQ-OQ-PQ documents in line with GLP & regulatory requirements.
6. To efficiently plan, coordinate and conduct day to day analytical activities of product development.
7. Transfer of analytical technology and methods to the manufacturing site regular QC testing.
8. Design and conduct in-vitro drug release testing of solid and semi-solid formulations with various dissolution techniques, development of discriminatory and bio-relevant dissolution methods.
To maintain and timely analysis of stability samples, compiling and tracking the trends of stability results.
To work closely with formulation development team and other cross functions, understanding the needs of project & active participation in technical discussions.
To coordinate with the contract research organizations for analytical development work for outsourced projects.
Assistances in Specification setting, OOS, OOT investigations, change controls & other GLP & quality practices.
To timely procure & maintain the inventory of regular analytical consumables and requirements.
Proactive and skillful in resolving technical problems during product development.
To ensure efficiency, quality, timely delivery of every analytical activity.
1. Proficient in GMP documentations and to assist in preparation of protocols & reports for analytical activities, and review the analytical data.
2. Comprehensive understanding of USFDA, EMA, MHRA, and ICH guidelines, and the regulatory requirements of various International Regulatory Agencies.
3. Good understanding of Polymorphism, Interpretation of Characterization data, ICH Stability Studies, compliance to 21 CFR Part 11, review support to regulatory submissions, and support to Intellectual Property Group etc.
4. Ability to communicate and influence crossfunctional teams to meet tight deadlines.
Experience: 10-12 Years
Qualification: M.Pharm, M.Sc, M.Tech
Functional Area: R&D
Industry Type: Pharma/Biotech/Clinical Research
End Date: 14th March, 2013
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