Manish Kumar Gupta

Building strategies, timelines and budget along with leading teams as matrix leader for end to end product development and technology transfer to commercial sites. leading innovation for localised drug delivery for implants and intravesical drug delivery. Enhancing collaboration with various CMO's .

Mumbai. JOB PROFILE Ensuring timely delivery of projects by Interacting with team members for flawless execution of the projects. Aligning systems according to global standards including the SOP and excipients and packaging material codes and specifications by interacting with Material Science and Packaging group. Preparation of business case and interacting with Capex committee for approval of Capex items. Implementation and training on Lean Management and its principles. Involved in preparation of Best Practices for streamlining and harmonizing across the globe sites. Identify and gain knowledge on PAT and its implementation, on Quality by Design, Design of Experiment and Criticality Analysis. Providing novel ideas on meeting the business needs and enhancing it. Preparing Product development reports, technology transfer reports, Criticality analysis report and other regulatory documents like setting product specifications and stability protocol with Analytical Development team.

Mumbai. JOB PROFILE Managing the initiation of discussions for feasibility studies with overseas CMC team Participate in telecons, prepare update reports on ongoing projects to keep customers briefed on progress of projects , also prepare final reports for closing of projects The design and execution of experimental programs to develop clinical and commercial formulations Development of systems according to GMP requirements like preparation and implementation of SOPs and work instructions as and when required and ensure that the team members work according to the SOPs, GMP and GLP Interact with Contract Manufacturing departments to manage the project development activities at their site in liaison with international customers. Managing vendors, external contractors, for successful installation and qualification of the process equipment. Play a lead role during audits by customers and regulatory agencies by coordinating with Department head and Drug product QA Director Ensuring ongoing training programs within department to ensure continuous growth of department personnel. Responsible for facilitating the functioning of pilot plant facility in qualification of new eqipments.

Ahmedabad. JOB PROFILE Review projects and identify Early Warning Signals & on-time Escalations Prepare Project Plan based on formulations development strategy and risk analysis. Provide expert formulation input to the design of experiments to investigate formulation and processing parameters for specific projects. Manage the day to day activities of the formulation development group and co-ordination with team members of other departments. Work closely with colleagues to ensure that appropriate information is generated and evaluated so that pharmaceutical development strategies are based on sound scientific rationale. Investigate issues that arise during formulation development/scale-up and work closely with other resources to determine the root cause and potential solutions. Design stability studies for formulated drug products to support formulation selection and applications to regulatory agencies. Where applicable, evaluate data from comparative BE studies and determine implications for project plan. Ensure pharmaceutical development activities undertaken are in accordance with current regulatory and quality standards and that pharmaceutical development reports generated are suitable for inclusion in regulatory submissions. Support marketing to answer customer technical queries. Provide technical support to Manufacturing, Quality assurance, Regulatory affairs in the introduction of new products and Technology Transfer Preparing budgets related to capital, revenue and manpower for the formulation development department

Ph.D

M.Pharm