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: Analytical Manager
Job Description:
Reporting to the AVP (R&D, Formulation) you will be individually responsible for:
1. Managing Analytical Method Development and Validation to support filing of DMF's, ANDA's and NDA's.
2. Carrying out Specification setting, Impurity Characterization, Polymorphism, Interpretation of Characterization data, ICH Stability Studies, Compliance to 21 CFR Part 11, analytical Support to Regulatory Submissions, and supporting the Intellectual Property Group etc.
3. Supporting the development of chromatographic and spectroscopic analytical methods for finished dosage projects (FDP) for regulated markets.
4. Creating tailor made SOPs, laying down standard development processes through guidance’s for effective functioning of the department.
5. Taking end to end responsibility to support the multiple FDPs for regulated markets by day-to-day analytical planning & execution.
6. Displaying familiarity of both technical and professional management of external teams and technical coaching of internal colleagues to deliver projects within deadlines.
7.Carrying out New analytical method development and validations for NCE's, API's and FDP's.
8. Helping in transferring technology to the manufacturing site for regular QC testing and analysis.
9. Displaying proficiency with Method validations (analytical testing as well as cleaning methods), Impurity profiling by LC-MS, Thermal techniques, Gas Chromatography, Particle size and polymorphism.
10. Using the science of sampling, defining, isolating, concentrating, and preserving samples; to set error limits; validate sampling plans and verify results of analysis.
11. Carrying out planning, procurement, installation, and periodic (re)calibration and standardization of analytical equipment to set up and maintain a GLP compliant analytical testing lab.
12.Maintaining Project-wise documentation of all the development activities, creating formats for data updating and release to stakeholders for regular analysis as well as stability studies.
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Candidate Profile:
With a MSc/MTech/MPharma/MS/PhD in Analytical chemistry, pharmaceutical chemistry or organic chemistry, you have worked for 7-14 years in the Analytical research function specifically in the regulated markets out of which atleast 6 years shall be in managerial position. You have displayed expertise in Analytical Research & Development, Stability Studies and Quality Management Systems with excellent people management skills and possess a sound understanding of regulatory compliance. A complete understanding of FDA, EMA, MHRA, and ICH guidelines, and the regulatory requirements of International Regulatory Agencies is mandatory. Experience in setting up an entire analytical development lab will be an added advantage.
Additional Information:
Experience: 7-14 Years
Location: Bangalore
Education: M.Pharm, M.S, M.Sc, M.Tech, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Skills: Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry
End Date: 21st June, 2012
Job ID: HC/JC/1269/12
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