Job title: Site Technical Support Lead
Location: Cambridge, MA / Framingham, MA / Morristown, NJ / Swiftwater, PA
About the job
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.
Department Description:
External Manufacturing and Supply (EM&S) Vaccines & LM GenMed organization is accountable for all Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing of Sanofi products. We serve the Global Business Units within Manufacturing & Supply (M&S) with drug substance, drug products, and finished goods, aiming to develop ourselves into a best-in-class organization that continuously strives towards three priorities – (i) Ensure Supply On-Time In Full, meeting all Quality and compliance standards, (ii) Deliver Financially, and (iii) Grow Talent. In addition to Running the Business, we are committed to Transforming the Business by defining our strategic global footprint for preferred partners and deploying the right technology in centralized performance management of partners.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
The EM&S Vaccines & LM GenMed Site Technical Support Lead willwork
in partnership with:
External Manufacturing & Supply (EM&S) core and business teams
Manufacturing Science and Technology (MSAT)
GDPU
Global business units (Vaccines and General Medicine)
Strategy & Project Portfolio Management
All other site and above site functions, as needed
To perform the following:
Ensures on time & in full delivery of products for CMOs/External Suppliers within site management unit by being present at the contract manufacturing site during key manufacturing activities (pFMEA, PPQ readiness & execution, manufacturing campaign challenges, improvements projects).
Accountable to understand the products as it is implemented at the CMOs from an operational and financial perspective, able to provide routine technical support, and provide timely information to all stakeholders.
Build collaborative business relationships with external partners as key partner to ensure on time & in full delivery by frequent presence at the CMO site.
Support escalation to the External Manufacturing Product Teams as it relates to problems encountered with CMO activities & production.
Actively participates in CMO driven Joint Steering Committee (JSC) meetings. Escalates issues to appropriate forums, as needed.
Accountable to understand the contract guidelines and the impact to the product/departmental P&L of production variations.
Responsible for implementing Life Cycle management projects.
Responsible for the adherence to the Risk Management Program to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involves a multi-disciplinary team to define remediation plans to mitigate risks impacting products and GxP operations.
Ensure Compliance through active participation at all applicable quality governance forums (including Quality Management Reviews and Periodic Business Reviews). Accountable for reviewing and providing technical of critical deviations. Accountable for on time Quality System related records, also reviews and approve all Category 3 Change Requests.
Works with EST and Functions heads for standardization of processes and procedures required to manage CMOs and related work within External Site Team.
About You
Bachelor's degree with 10+ years' experience or master's degree with 8+ years' experience.
Proven track record in operational leadership roles (e.g., Site Manager, SLT member, MSAT, Production or Technical Manager)
Extensive knowledge of vaccine/biotech/pharmaceutical operations and processes
Strong understanding of industrial business processes and data management, with exposure to AI digital products
Proficiency in end-to-end product & industrial strategy, performance management, and project management
Demonstrated analytical skills and expertise in KPI target setting & monitoring
Cross-site and cross-GBU networking experience preferred
Special Working Conditions:
Travel: domestic and/or international up to 40%
Language(s): English fluent, French as a plus
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
