
Job Overview
Compensation
Salary
Range $133,500.00 - $192,833.33
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Parental leave
wellness programs
Career development programs
financial rewards
Job Description
Sanofi is a global biopharmaceutical company renowned for its research and development-driven approach, committed to innovation in medicines and vaccines. Operating at the cutting edge of science, Sanofi leverages artificial intelligence and extensive experience in immunology to develop treatments that protect and improve lives worldwide. With a mission grounded in delivering high-quality healthcare solutions, Sanofi is dedicated to continuous growth, technological advancement, and contributing to global health by combating infectious diseases and chronic conditions alike. The company has a worldwide network of teams and manufacturing sites, fostering an inclusive culture that values diversity, development, and employee wellbeing. Sanofi's commitment to a sustainable future and scientific excellence makes it a leading biopharma entity recognized across the globe.
The Operations Lead for Vaccines at Sanofi is a critical leadership role based in Cambridge, MA, within the EM&S Vaccines Operations department. This operational unit is responsible for ensuring the on-time and in-full delivery of vaccine products from Contract Manufacturing Organizations (CMOs) and external partners. The Operations Lead's role involves managing the entire contract execution process, ensuring compliance and seamless collaboration with CMOs, external partners, and internal teams such as Quality, Supply, Procurement, Finance, and Regulatory Affairs. The position demands strong project management capabilities and the ability to lead cross-functional teams through technical transfers, new product introductions, and continuous improvement initiatives in vaccine manufacturing operations.
The Operations Lead acts as the primary Sanofi interface with manufacturing sites, effectively serving as a virtual plant manager by overseeing production, supplying critical updates, and managing risks related to quality or product supply. This role includes overseeing planning consistency, contract compliance, and production capacity alignment with contract obligations, while ensuring the smooth flow of materials and products. The candidate will also coordinate all related industrial flows between partners and Sanofi sites, manage purchase orders in ERP systems, and escalate risks and issues when necessary to senior management. Participation in audits, quality investigations, and compliance initiatives is also a key responsibility.
This position requires strategic thinking, outstanding communication skills, and profound knowledge of pharmaceutical manufacturing processes and regulations. The Operations Lead will routinely collaborate with various internal functional units and external partners to drive operational excellence and timely product delivery. The role supports Sanofi's mission to deliver billions of healthcare solutions annually by protecting people from infectious diseases and advancing medical innovation. Opportunities for professional growth, international travel (up to 20%), and involvement in high-impact projects make this a prestigious and challenging role for operations professionals with extensive industry experience.
The Operations Lead for Vaccines at Sanofi is a critical leadership role based in Cambridge, MA, within the EM&S Vaccines Operations department. This operational unit is responsible for ensuring the on-time and in-full delivery of vaccine products from Contract Manufacturing Organizations (CMOs) and external partners. The Operations Lead's role involves managing the entire contract execution process, ensuring compliance and seamless collaboration with CMOs, external partners, and internal teams such as Quality, Supply, Procurement, Finance, and Regulatory Affairs. The position demands strong project management capabilities and the ability to lead cross-functional teams through technical transfers, new product introductions, and continuous improvement initiatives in vaccine manufacturing operations.
The Operations Lead acts as the primary Sanofi interface with manufacturing sites, effectively serving as a virtual plant manager by overseeing production, supplying critical updates, and managing risks related to quality or product supply. This role includes overseeing planning consistency, contract compliance, and production capacity alignment with contract obligations, while ensuring the smooth flow of materials and products. The candidate will also coordinate all related industrial flows between partners and Sanofi sites, manage purchase orders in ERP systems, and escalate risks and issues when necessary to senior management. Participation in audits, quality investigations, and compliance initiatives is also a key responsibility.
This position requires strategic thinking, outstanding communication skills, and profound knowledge of pharmaceutical manufacturing processes and regulations. The Operations Lead will routinely collaborate with various internal functional units and external partners to drive operational excellence and timely product delivery. The role supports Sanofi's mission to deliver billions of healthcare solutions annually by protecting people from infectious diseases and advancing medical innovation. Opportunities for professional growth, international travel (up to 20%), and involvement in high-impact projects make this a prestigious and challenging role for operations professionals with extensive industry experience.
Job Requirements
- Bachelor's degree in engineering, Supply Chain Management, Operations or Manufacturing Management or any relevant field with extensive experience
- master’s degree in related fields with significant experience is acceptable
- proven experience in operational roles
- strong knowledge of drug product and drug substance manufacturing processes
- thorough understanding of pharmaceutical regulations including US, JP, EUR standards
- project and program management skills
- experience in the biotech or pharmaceutical industry preferred
- competency in data analysis, trending, and effective communication in multifunctional teams
- willingness and ability to travel worldwide up to 20% of the time
Job Qualifications
- Bachelor's degree in engineering, Supply Chain Management, Operations / Manufacturing Management or any field with 10+ years of experience
- Master's degree in engineering, Supply Chain Management, Operations / Manufacturing Management or any field, with 8+ years of experience
- experience in operational roles
- good knowledge of DP/DS manufacturing processes
- good knowledge of pharmaceutical regulations (US, JP, EUR etc.)
- 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
Job Duties
- 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
- 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
- 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
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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