Summary
The Life Cycle Manager (LCM) leads projects within his area of responsibility and is responsible for the successful implementation. A successful implementation includes avoiding supply disruption and stock-outs, ensuring regulatory compliance, managing project timeline and budget, mitigating risks effectively and creating and executing an effective submission & implementation strategy.
About The Role
Life Cycle Manager
Location Hyderabad Hybrid
About The Role:
The Life Cycle Manager (LCM) leads projects within his area of responsibility and is responsible for the successful implementation. A successful implementation includes avoiding supply disruption and stock-outs, ensuring regulatory compliance, managing project timeline and budget, mitigating risks effectively and creating and executing an effective submission & implementation strategy.
Key Responsibilities:
- Lead projects for all Lifecycle events (LCE) in area of responsibility (DS, DP, FP for assigned Product(s). Successful implementation of Project/LCE in-time, budget, compliance
- Forms the project team during kick-off meeting in the initiation phase. Organizes and leads project meetings and arranges meeting minutes until hand-over to the Life Cycle Implementation Expert (LCI). Is responsible and accountable to develop together with the responsible functions in RA-CMC and RA the regulatory submission strategy and in conjunction with E2E-Supply Network Planning Manager, Sites, Markets and other stakeholder the implementation strategy.
- Identifies harmonization/bundling opportunities to reduce complexity. Is responsible to check the impact of the project on supply, possible interaction with other projects or brand related activities, ensures whenever needed the prioritization across Life Cycle Projects.
- Project Lead is accountable to ensure that the Master Data strategy is created by the responsible Master Data group. The Project Lead together with the LCI creates a first version of the changeover plan (COP) including affected assortment (provided by LCI), planned submission, planned approval and planned implementation timelines on SKU level
- Is responsible to distribute project information to sites and markets (incl. COP) to trigger initial local data set-up (planning BOM, material master data, sales forecast etc.). The project lead only does the 1st communication of the COP Version 1 to the stakeholder, thereafter the LCI is responsible.
- Is responsible for project reporting and update in the applicable Life Cycle (LC) reporting tool. Is responsible for communicating relevant information after submission to affiliates (Demand Managers) and affected manufacturing site(s) (SCM line functions).
- Is accountable to ensure that all implementation activities are completed according to the project plan and the regulatory approvals in order to ensure a regulatory compliant implementation and that any changes to the project (e.g. timeline shifts) will be communicated.
Essential Requirements:
- Education: University degree (technical, science, pharmaceutical, project management, supply chain management preferred) or other education with equivalent experience in the pharmaceutical industry.
- 12 years in the biopharmaceutical industry, specifically in Large Molecules. Extensive experience in Life cycle management of DP, DS and FS
- Experience in execution of product launch, transfer, change, divestment, pruning, new product development.
- Experience in biopharmaceutical manufacturing aseptic/sterile manufacturing, in large molecules
- Preferred experience in Operations, Quality, Manufacturing Science, or related departments
- Very good communication skills, Project Management techniques, Analytical & structured approach, Problem solving in complex environments.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Commitment To Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
