Operations Lead Vaccines

Job Title:

Operations Lead Vaccines

* Location:

Cambridge, MA

About the Job

EM&S Vaccines Operations department is the operational unit responsible for ensuring on-time and in-full delivery of products from CMOs (Contract Manufacturing Organizations) and External Partners. The team is also responsible for contractual compliance of the business and operational aspects with respect to CMOs and External Partners management and ensures all EM&S related functional aspects of Tech Transfers and commercialization into new CMOs are effective.

EM&S Vaccines Operations team interacts with functional units within EM&S LMGM V (Large Molecule general Medicine and Vaccines) Quality and Supply team, EMPT, Sanofi sites, and other organizations within Sanofi network (e.g., MSAT, procurement, supply chain, finance, affiliates…) to ensure compliance with internal (Quality, HSES, Finances…) and regulatory requirements, and to disposition intermediate (e.g., API, drug substance) and finished products with minimal risk to quality or product supply.

Within the framework of partnership contracts or Contract Manufacturing Organizations (CMOs), the External Manufacturing Operations Leader is responsible for the coordination and the execution of contracts and follow-up execution with Sanofi external partners in accordance with the supplier relationship managed by EMPT.

The position is accountable for leading the Execution Follow-up Meetings including oversight and management of activities in support of products manufacturing operations at the assigned CMO or partners, taking responsibility for delivery against the contract. The candidate is the primary Sanofi interface for all communications with site manufacturing activities (virtual plant manager) and is expected to manage operations and communicate effectively to create value in meeting Sanofi's business objectives.

The position may support all project management initiatives at the supplier site including tracking KPIs, manufacturing technical transfers, new product introductions, compliance initiatives and continuous improvement projects. The candidate will routinely manage and contribute to projects requiring close collaboration with Technical Development, Regulatory Affairs, Legal, Quality, Finance, Logistics, Planning and Business Operations.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

About Sanofi:

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities

Control of the partners relationship and monitor the execution of contracts:

* Manage the implementation of new flows and optimize them

* Co-write the new specifications (PTS) in project mode under the leadership of Tech transfer team and manage the changes for the specifications in routine mode.

* Ensure that the CMOs and MAMPs carry out the productions according to the Specifications and contracts in place.

* Ensure that production capacity is aligned to requirements and contract obligations.

Manage the production/release flow of subcontractors to meet customer commitments (deadlines/quantities/quality):

* Follow plan made by global Supply Chain for Vaccines

* Guarantee the proper execution of production plans between External Partners and Sanofi on Partners sites within a short-term horizon of 0-6 months, for on-time, in-full delivery of product from partner to customers.

* Follow production indicators.

* Coordinate deviations and Change controls (timing and release impact, creation of internal quality event if necessary…) in collaboration with EM&S LMGMV quality, Sanofi site/entity QP and quality team of the affiliate when applicable.

Coordinate all…