Primary Job Responsibilities
Support EPD and EPO India Financial goal Support EPD goal to achieve 3% growth on base business through timely launch of new products Relook and improve the NPI Ops BD processes for AIL & ASC. Support annual budgeting activity and RLBE submissions for NPIs. Coordinates with multiple stakeholders (Within Abbott and external) for each new product launch. Negotiate with the TPMs for better price, lot sizes and lead times for the new products. Ensuring correct DPO (payment terms) negotiation and control. Networking with API suppliers for key NPI API to gather market intelligence. This helps us in better negotiation and cost control. Complay with the contracting process with TPMs. Support to I&D to ensure smooth launch of new product. Support by adding new products from existing strategic sites or sourcing the same from within the existing network Contribute in TPK reduction project by launching maximum TPM products. Timely deliver the launch quantity of new product and then streamline the delivery process and and handover the product / sites to the Strategic sourcing and Tactical sourcing teams. Timely due-deligence and streamlining post launch activities for L&A project Comply with purchasing policies, Pharmacopeial, Quality and regulatory requirements. Team development for Ready now and ready later successors.
Primary Job Function
Ensure timely launches of New products as per the launch plan (annually approx 50 SKU's) Carry out due diligence activities and identify and highlight related business risks, if any, for the Third-Party Manufacturer (s) prior to contract negotiation and finalization. Ensuring Site Selection in adherence to internal TP Strategy and TP rationalization initiatives Carry out contract negotiations with the Third-Party Manufacturer with respect to costs, supply timelines, batch sizes and capacity and other terms and conditions of the contract Work on screening, evaluating, and executing Third Party Manufacturing contracts for all NPI products of Abbott EPD in India especially for AIL & ASC affiliates. Manage smooth handover of the ongoing contract execution and relationship management with the External manufacturing team to ensure post launch delivery execution Third Party Relationship management to understand the latest technology development at TPM end. Understanding the pharma market product pipeline, technology offerings and infrastructure capability Comply with Corporate Purchasing Policies, CQA requirements, Regulatory requirements, Pharmacopeia requirements, NLEM / NPPA requirements etc. Implement strategic initiatives such TP Connect, TP Rationalisation, TPK reduction Support I&D external manufacturing NPI project from the development to final delivery as relationship manager, finalising the shadow costing, prototype costing and commercial batch costing
Licensing & Acquisition (Operations)
- Responsible for operational assessment of deals as they apply to EPO (supply continuity, cost of goods, in-house manufacturing potential)
- Be a part of the cross-functional project teams to review in-licensing, out-licensing and divestiture opportunities that EPD Licensing & Acquisitions is actively pursuing
- Equip the L&A team with operational terms in licensing and divestiture contracts
- Represent EPO in all deal activity in the assigned region. Evaluate proposed contractual relationships with external parties to source molecules for the EPD portfolio through the following types of contractual relationships:
- In-licensing of products
- Distribution agreements
- Divestitures
- Product Acquisitions
- Local Company Acquisitions (with support of direct management)
Additional Responsibility Is To
- Post launch support for demand variation, issues in packaging/formulation and sales to PS conversion in new product launches
- L&A projects post deal closure transferring the products to strategic partners
Core Job Responsibilities
- Work closely with internal teams like NPI / BD, I&D, Legal from the perspective of supporting the project timelines and ensuring identification of the right TPM for the NPI product and launches as per agreed timelines
- Participate in the Innovation Boards Meeting, Weekly NPI update Meeting, Monthly NPI Marketing meetings for the various affiliates and provide inputs in terms of third party manufacturing options, timelines, costs etc. for NPI products
- Ensure a keen understanding of the TPM landscape in the country to be able to identify reliable partners for a particular product type keeping in consideration the requirements of technology, infrastructure, capacity, cost efficiency etc.
- Timely execution of agreements/addendums of new products
- Putting process in place for new product launch execution
- Training and development for the successor
Key deliverables for I&D
- Be the commercial bridge between I&D and TPM network
- Liaise with I&D team to identify and assign appropriate TPM options for development projects which are ready for scale up
- Lead negotiations for development contracts with TPM partners in close collaboration with I&D team. Deliver executed development agreements within the expected budget parameters in line with project timelines
- Support I&D in the commercial aspects of operationalizing the developments contracts viz scheduling, purchase orders, payments, process validation, data release and first lot quality release
- Understand upcoming pipeline requirements at I&D and develop the TPM network proactively in line with upcoming requirements in terms of capability, capacity, and compliance
Skills
- Understanding of the product development process
- In dept knowledge of the product development cost
- Negotiating and closing development agreements
- Stakeholder management
- Network with established and upcoming TPMs
Supervisory/Management Responsibilities
Individual contributor
Education & Experience
- B.Pharm/BE
- 10 years+ in Pharmaceutical Manufacturing / External Manufacturing