Job Description

Department Details

Role Summary

Formulation Development Injectables R&D

Key Responsibilities

• Quality support to developmental activities at R & D to ensure that the data and technology transfer to commercialization sites are accurate, adequate, robust and meeting the facility requirements with respect to cGMP, GLP, GDP and corporate procedures.
• Monitoring submission of all the documents required for applying various regulatory approvals such as Test License, Import License, BENOC etc.
• Monitoring procurement of Reference product, API, Excipients, Packaging materials, tooling, change parts and newer instruments required for product development.
• Discussion with various stake holders such as IPM, RA, QA, CPPK, Analytical R&D, Packaging development team, Production team, QC, Engineering and PM/BD to decide upon a common project plan.
• Review of Literature and Patents and designing a development strategy.
• Designing prototype formulation development strategy and discussion with IPM and RA for their inputs.
• Monitoring of pilot BE study execution and interpretation of results, day to day formulation development activity and documentation and execution of formulation and process QbD.
• Data compilation, review and interpretation, discussion and presentation with various stake holders.
• Discussion with ARD, RS and DQA to propose IP and FP release and stability specifications.
• Review of literature, patents and designing a development strategy, various study protocols like Stability study, Photo-stability study, In-use study, Thermal cycling excursion study, Hold time study for executions of Exhibit batches at manufacturing site and MFC), BOM , MPC , Sampling protocol, different study plans and report for technology transfer submission.
• Co-ordinate with relevant functions like Project Management, Regulatory, TT, SOP, IOP, EOP, Guidance, Operations, Productions, Quality and Regulatory to ensure that the projects are planned and executed in a timely manner.
• Ensuring the appropriate documents in-place for execution of Scale-up and Exhibit batches.
• Monitoring execution of Scale-up and EB batches and Pivotal BE study and preparation of documents and generation of data required for filing
• Review the PDR and QbD documents by thoroughly capturing all the relevant data in a detailed yet concise manner ensuring the technical adequacy and completeness and specification and testing methodology of components of drug products prepared by Analytical/Quality Control functions and provide the timely review comments.
• Ensure all projects & technology transfers to be transferred are completed in a timely manner and Provide motivation, guidance and support to team members to achieve newer heights through scientific, on-site, verbal and non-verbal training
• Investigation of OOT and OOS generated during exhibit batches and handling of FDA queries for filed products and support manufacturing plant for technical trouble shooting.
• Support to manufacturing team for commercial launch activity and monitor the production activity as on need basis.
• Technical feasibility & costing of new products to support product selection.
• Guide and support to the team for generation of additional data and documents required for market extensions.
• To assess the developmental data and technology that are built on QbD & QRM and handling of regulatory queries and on time support for any regulatory and ROW filing.
• Monitor GMP practice pertaining to R&D and support to audit and compliance.
• Approval of PRN for the Consumable, API and Packaging materials in SAP.
• Perform all other duties, as assigned by reporting manager
• Presentation, collaboration, provide extended support to both internal and external teams to achieve organizational objectives.
• Follow the approved standard procedures, corporate procedures and company policies and perform all other duties, as assigned by reporting manager.

Educational Qualifications

Required Education Qualification: Ph.D
Required Experience: 10 - 15 years