Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post : Sr. Research Scientist
Job Summary
- Responsible for Technology Transfer of products from Formulation development to Commercial scale which includes performing Technical Risk Evaluation upon scale up/scale down of products prior to commercialization,
- Performing process optimization trials & Execution of Process Demonstration batches
- Providing support and Monitoring of Process Validation batches.
- Technology Transfer for Products from Outside to ARPL and Vice-versa.
- Review of Technology transfer package, manufacturing process comparison, performing feasibility and optimization trials, planning and generation of the manufacturing documents for execution of batches at ARPL.
- Product life cycle management (Alternate API source qualification by taking feasibility/optimization trials and submission batches & Product quality improvement).
- Work as a team and support our corporate values.
Job Responsibilities
- To Perform Technical risk evaluation of the product and process.
- Evaluating the requirement of Demonstration batch and optimization batch for New Product Launch and site transfer products based on the regulatory requirements and technical risk evaluation.
- Preparation of Process Demonstration batch protocol and Report and circulate for review and approval, to recommend any modification in Formulation, equipment and in process after completion of Demonstration /optimization batch.
- To perform Technical investigations and reports if any for the closure of AQRS and Market complaints.
- To Monitor Process validations of New product launch, Site transfer products from internal (SVMP to LVMP) and External (from Apotex Inc to SVMP/LVMP) and Review process Validation protocols and Reports.
- To Review site transfer projects documents and execute the Feasibility trails, optimization trails and generate documents required for the execution of Submission, Demonstration or commercial batches as applicable.
- To take feasibility trails and optimization trails for Alternate vendor for API, and generate the documents required for the execution of Submission batches.
- Trouble shooting of issues raised during commercial batches execution.
- To perform the Equipment qualification activities and documents for the same as protocols and reports
- To generate and revise various documents like SOPs, Formats, Protocols, Reports, Master formulas, Packaging Order Masters etc.
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Candidate Profile
Education: Master Degree in Pharmacy. Specialization in Pharmaceutics / Industrial Pharmacy is desirable.
Experience: Should have minimum 5 to 7 year experience in Technology Transfer of the Pharmaceutical product.
should have knowledge of process development and Technology transfer on Solid dosage forms for regulated markets like USA, Europe, Canada and Australia is essential. Should have a good understanding of Product development process along with scale-up knowledge of the product and Process Validation. Should have good understanding of clinical and regulatory requirements of USA, Canada, Australia, and European regulatory agencies. Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.
Other Information:
Experience: 3 to 5 years
Location: Karnataka - Bangalore
Education: M.Pharm
Industry Type: Pharma/biotech/Clinical research
Functional Area: R&D
End Date: 25th November, 2017
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