Operations Lead Vaccines

Sanofi•Cambridge, MA

1d•$133,500 - $192,833•Onsite

About The Position

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 tech 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.

Requirements

Bachelor's degree in engineering, Supply Chain Management, Operations / Manufacturing Management or any field with 10+ years of experience OR Master’s degree in engineering, Supply Chain Management, Operations / Manufacturing Management or any field, with 8+ years of experience
Experience in operational roles is required
Good knowledge of DP/DS manufacturing processes
Good knowledge of pharmaceutical regulations (US, JP, EUR...)
Project/program management experience is extremely helpful
Working knowledge within biotech/pharmaceutical industry is highly preferred
Experience with data analysis, trending, and presenting material within multi-functional environment.
Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
This job position requires the ability to travel worldwide for 20 % max of the time.

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 industrial flows between Partners and Sanofi sites: Lead the execution follow-up in accordance with the planned commitments for all areas supporting external partners (QA, QC, Supply, Logistics, Operations, MSAT, affiliates…) ensuring cross functional representation and participation.
Manage purchase orders from procure to payment for Vaccines CMOs in ERP
Escalate key risks and issues to senior management, EMPT and risk manager.
Monitor partner performance (KPIs) against production goals, identify and resolve gaps, and ensure standard governance model is implemented to track performance.
Participate in quality audits and inspections in collaboration with EM&S LMGMV Quality (at least for preparation and closure meeting)
Participate in investigations related to customer complaints/CAPA and audits.
Contribute to Binding Offers and project definition if requested by the EMPT.
Manage tech transfer projects as project manager/leader if requested by EMPT or contribute to the project as project team member.