Vacancy for M.Pharm as Senior Research Scientist at Apotex Research

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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

  1. 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,
  2. Performing process optimization trials & Execution of Process Demonstration batches
  3. Providing support and Monitoring of Process Validation batches.
  4. Technology Transfer for Products from Outside to ARPL and Vice-versa.
  5. 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.
  6. Product life cycle management (Alternate API source qualification by taking feasibility/optimization trials and submission batches & Product quality improvement).
  7. Work as a team and support our corporate values.


Job Responsibilities

  1. To Perform Technical risk evaluation of the product and process.
  2. 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.
  3. 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.
  4. To perform Technical investigations and reports if any for the closure of AQRS and Market complaints.
  5. 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.
  6. 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.
  7. To take feasibility trails and optimization trails for Alternate vendor for API, and generate the documents required for the execution of Submission batches.
  8. Trouble shooting of issues raised during commercial batches execution.
  9. To perform the Equipment qualification activities and documents  for the same as protocols and reports
  10. To generate and revise various documents like SOPs, Formats, Protocols, Reports, Master formulas, Packaging Order Masters etc.

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