Emcure - Project Management Role - R&D Development - API

API Project Management-R&D development to Filing

1. Responsible for project management of New Product Introduction (NPI) of API projects for US, CAN, EU, Brazil, China, ROW/Emerging

2. Preparation of project plan with milestone for process & analytical development, scale up, validation, stability until filing.

3. Initiation of project plan, monitoring of schedule in development (R&D) for planned vs actual.

4. To coordinate between R&D, Operation and Formulation team/ sites in case of captive API transfers. Ensure integration of necessary information between formulation and API teams on expectation quantity, quality, specs and MOA of API.

5. Prioritization of R&D resources and alignment as per organizational priorities

6. End to end project management of key products in domestic market from identification, planning, execution, monitoring of products intended for domestic market.

Single point of contact from R&D and API Operation

1. Ensuring and providing readiness timelines of projects from R&D as per NPI SOP.

2. Providing monthly/annual batch manufacturing plan on scale up and validation batches. Monitor for Planned Vs Actual.

3. To coordinate and synchronize the transfer of API process from R&D to Operation for smooth tech transfer to plant.

4. Preparation of plan for Cost improvement (CIP) and Process improvement projects (PIP) from R&D to Operation: Track RMC and timelines target for planned vs actual.

5. Coordinate support required by API operations in troubleshooting, investigation and closure of LIR etc.

6. To coordinate and align the schedule of transfer of API to Pharma: Track committed supply date of API vs actual timeline.

7. Be the R&D representative in a various meetings of API BU (Monthly review, launch review, SnOP, CIP and PIP projects, Operation and R&D etc)

8. Preparation of updates for various R&D and APO operation meetings.

New Production selection, API Sales support

1. New Products identification, selection, co-ordination with all functions to collect data on market potential, IPD and market analysis

2. Estimate the resources, Investment, budget and schedule required to develop the new products.

3. Support API sales team on various customer queries on API for third party sales.

General API Project Management:

1. Ensure Projects Budgets-Project Initiation (Preparation, Monitor and Control)

2. R&D Capex (Preparation, Monitor and Control)

4. Review and approve analytical purchase orders for columns, impurities, standards

5. Management Dashboard preparation and circulation-monthly

6. R&D MIS

7. Resource mapping, allocation and approval in API R&D

8. HPLC Utilization and analytical occupancy mapping in R&D