Clinical Supply Chain Global Production Enablement Lead (GPEL)

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, a member of the Roche Group.

The Opportunity

As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function
ensures that packaging operations can produce material required by Roche's clinical trials
seamlessly, on-time, and while optimizing cost/quality.

Within Production Enablement the Global Production Enablement Lead team is responsible to
collaborate with support groups to ensure a timely and effective delivery of clinical products.
They incorporate study, product, and process knowledge to enable efficient processing from
initial supply set-up to depot receipt. This includes making decisions regarding kit designs,
booklet selection, system set-up, and material availability all to ensure smooth order
management, timely production, finished good release, and delivery to Roche depots in
accordance with the local standard and regulatory requirements.

What You'll Do

• You will collaborate with the planning organization as the initial point of contact for new product requirements and support new molecule introduction, molecule oversight and initiate work center activities within the Product Enablement organization.

• You are accountable for determining standard and non-standard configuration and ensure kit design feasibility, driving the evaluation and identifying solutions for new molecules and the required configuration in collaboration with partners (e.g. Planning, Manufacturing, Packaging and Device Development, etc)

• You are accountable for the readiness of materials to support study timelines. Enable successful order preparation and drive "on-time in-full" production. You are also the first point of contact for escalation within the Product Enablement organization

• You will drive decisions as well as address and resolve issues with impact to the end-to-end order Lead Time from Source to Deliver. In addition, you are responsible for triggering order change requests and expediting orders (as needed). You will coordinate timelines with the Master Production Scheduler.

• You will perform impact assessment for new projects on different functions, e.g. large capacity, new technology, shipping requirements and actively participate in global and local projects such as kaizens to optimize clinical supply. In some cases you will lead local/global projects specifically to improve in-house/sourced packaging.

• You will actively monitor Key Performance Indicators (KPIs) for team performance, production readiness and in-house production enablement activities and work independently to develop ideas and initiates regarding continuous improvements according to the Roche PT Lean Production System (LPS) initiative.

• You will collaborate with Business Process Managers to exchange ideas, drive process improvement, and resolve issues on a global level; support system improvements, create and revise SOPs and training documents.

Who You Are

• You have a bachelor's degree (or equivalent) in Business (Economics, Operations Management, Supply Chain Management), Life Sciences or Engineering. A Master's degree is a plus.

• You have 5+ years of work experience in the GMP environment (e.g. pharmaceutical or food industry) or in equivalent supply chain functions

• You have previous ERP system experience, (e.g. SAP, OMP or APO)

• You have experience in project management and in a cross-functional and cross-cultural environment

• You have previous experience in application of production efficiency methodologies (5S, Lean Manufacturing, Six Sigma, and/or Theory of Constraints)

• You have demonstrated experience in matrix leadership in a changing environment

• You have APICS and/or SCOR certification, or associated relevant experience

• Experience in clinical operations, technical drug development, regulatory or quality is a plus

• PMP/Operational Excellence/Six Sigma/Lean training a plus

Relocation Funding is not available for this position

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