Sanofi
M and S EM and S SPPM New Product Introduction Leader
Sanofi, Cambridge, Massachusetts, United States, 02141
M And S Em And S
Sppm
New Product Introduction Leader
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. Reporting to the Head of SPPM - EM&S Strategic New Products Introduction LM/SM Vx & SpC or Head of SPPM - EM&S Strategic New Products Introduction GenMed, you will lead strategic projects for EM&S, supporting Sanofi growth (New Launches, strategic dual sourcings, Tech Transfers), and Licensing IN/OUT transactions ensuring full alignment with EM&S, M&S, R&D. Represent External Manufacturing management in decision committees regarding these projects. Ensure efficient project management, with disciplined methodology, budget and planning adherence, thoughtful risk taking and continuous processes optimization. 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
Main responsibilities include: Lead project management for New Product launches/Tech Transfer dual sourcing in CMOs. Lead all Project activities related to CMOs, with cross-functional EM&S teams (quality, supply, operations), associated business partners (Finance, Procurement, MSAT, R&D) and CMOs. Set-up the project team. Define the potential targeted sourcing CMOs and coordinate Request for Quotation with Subject Matter Experts (SMEs): quality, supply operations, MSAT, R&D, HSEn finance. Support CMOs selection recommendation with +QDCI approach and including planet Care assessment. And set-up the business case (Opex, Capex, resources, cost/batch, NPV etc.) Define Project planning and milestones. Track, measure and proactively communicate on progression. Define budget and ensure budget adherence. Provide and maintain proactive risk management and mitigation plans. Ensure, in collaboration with Procurement and EM&S operations, key commercial deal terms negotiations for commercial activities. Ensure lean governance with efficient accountability. Anticipate decisions to be made and proactively propose scenarios. Apply DAI (Decision makers, advisors, Informed stakeholders). Contribute to standardization/modernization initiatives on NPI/TT. Ensure appropriate coordination with all stakeholders, Global launch leader, R&D, Global supply Chain, internal sites if any, countries. Business Development Licensing IN
Contribute on BDs projects for what relates to CMOs activities. Conduct Due diligence in BDs on the manufacturing and supply activities, when applicable to CMOs, in a timely manner. Due diligence and risk assessment: Identify any risks related to capacity, compliance, supply continuity, and overall manufacturing capability. Contribute to the business case assessment. Contribute to the negotiations of key commercial deal terms for activities post-closing. Provide recommendations for mitigations, for future sourcing, for integration, for contract management, for budget anticipation. Bring visibility with clear communication to EM&S and M&S leadership team. Lead transition to EM&S operation when transaction is signed for CMOs-related. Licensing OUT
Lead project management on Portfolio divestment projects for what relates to CMOs. Coordinate internal Due diligence with EM&S teams (supply / Quality / Operations), as well as with Legal, finance and procurement business partners. Provide and communicate proactive risk assessment, with mitigation plans and/or risk acceptance when applicable. Assess and communicate on business case impacts. Define and negotiate contract management strategy with new buyers. Coordinate with EM&S teams all activities until MAT (Marketing Authorization Transfer) / effective project closure. Lead transition to EM&S operation from transaction is closed to MAT. The New Product Introduction Leader will be responsible for the management and implementation of cross-functional teams, as well as continuously improving effectiveness of the SPPM tools and processes: Provide leadership and direction to assigned project team members. Institute comprehensive work breakdown structures for all team deliverables; track and follow up on implementation of team decisions. Identify resource and schedule constraints, key risks and issues to be resolved, and proactively drive the development of contingency and/or risk mitigation plans. Ensure proper and timely communication to the relevant stakeholders, incl KPIs, meeting minutes, dashboards and management reports/presentations. Ensure the respect of project commitments (budget, milestones & deliverables). Drive decision making to the relevant stakeholders (Capex/OPEX, Sourcing, Capacity, resources, prioritization, timing). Scope
All technologies, in large and small molecules. Projects defined below are requiring expertise navigating in complex, strategic environments with either Overall project CapEx + OpEx + CMO commitments ? 15M and/or peak sales ambitions > 1B and/or Sanofi BOI contribution > 100M. About You In addition, SPPM Project Leader is expected to: Work independently under minimal supervision and direction. Participate and lead in determining objectives of significant projects or assignments. Perform work that requires decision making and the consistent exercise of independent judgment and discretion. Soft Skills
Strategic thinking: Analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focus on priorities. Able to shape a vision. Able to lead & animate networks, teams, experts - Strong communication skills Results orientation: Demonstrated ability to drive initiatives from concept to execution High level of autonomy. Executes, comfortable with ambiguity, and adapts with agility. Takes calculated risks and anticipates potential issues. People development: Engages and leverages everyone's strengths while being highly self-aware. Instore the culture of feedback & empower people to grow & manage his/her career path. Relationship & Influence: able to manage ambiguity and partners without solid reporting line Stretched ambition and take action. Encourages the teams to stretch and do things differently & creates space for the teams to take action. Commit to Patients and full product quality. Makes sure the teams understand how to act for patients and customers. Approaches the role with humility and thinks Sanofi first. Basic Requirements
Bachelor's degree in Biology/Pharma/Chemistry or other scientific discipline Minimum of 12 years' experience in technology transfer within biopharmaceutical manufacturing Strong experience in Project Management Prior experience working with external manufacturers/CMOs is strongly preferred but not required. Technical Skills
Knowledgeable in E2E product & industrial strategy, new product launches, project management Robust financial understanding Excellent communication, interpersonal skills and experience working within a matrix organization Good understanding of data management and IA digital 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
Sppm
New Product Introduction Leader
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. Reporting to the Head of SPPM - EM&S Strategic New Products Introduction LM/SM Vx & SpC or Head of SPPM - EM&S Strategic New Products Introduction GenMed, you will lead strategic projects for EM&S, supporting Sanofi growth (New Launches, strategic dual sourcings, Tech Transfers), and Licensing IN/OUT transactions ensuring full alignment with EM&S, M&S, R&D. Represent External Manufacturing management in decision committees regarding these projects. Ensure efficient project management, with disciplined methodology, budget and planning adherence, thoughtful risk taking and continuous processes optimization. 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
Main responsibilities include: Lead project management for New Product launches/Tech Transfer dual sourcing in CMOs. Lead all Project activities related to CMOs, with cross-functional EM&S teams (quality, supply, operations), associated business partners (Finance, Procurement, MSAT, R&D) and CMOs. Set-up the project team. Define the potential targeted sourcing CMOs and coordinate Request for Quotation with Subject Matter Experts (SMEs): quality, supply operations, MSAT, R&D, HSEn finance. Support CMOs selection recommendation with +QDCI approach and including planet Care assessment. And set-up the business case (Opex, Capex, resources, cost/batch, NPV etc.) Define Project planning and milestones. Track, measure and proactively communicate on progression. Define budget and ensure budget adherence. Provide and maintain proactive risk management and mitigation plans. Ensure, in collaboration with Procurement and EM&S operations, key commercial deal terms negotiations for commercial activities. Ensure lean governance with efficient accountability. Anticipate decisions to be made and proactively propose scenarios. Apply DAI (Decision makers, advisors, Informed stakeholders). Contribute to standardization/modernization initiatives on NPI/TT. Ensure appropriate coordination with all stakeholders, Global launch leader, R&D, Global supply Chain, internal sites if any, countries. Business Development Licensing IN
Contribute on BDs projects for what relates to CMOs activities. Conduct Due diligence in BDs on the manufacturing and supply activities, when applicable to CMOs, in a timely manner. Due diligence and risk assessment: Identify any risks related to capacity, compliance, supply continuity, and overall manufacturing capability. Contribute to the business case assessment. Contribute to the negotiations of key commercial deal terms for activities post-closing. Provide recommendations for mitigations, for future sourcing, for integration, for contract management, for budget anticipation. Bring visibility with clear communication to EM&S and M&S leadership team. Lead transition to EM&S operation when transaction is signed for CMOs-related. Licensing OUT
Lead project management on Portfolio divestment projects for what relates to CMOs. Coordinate internal Due diligence with EM&S teams (supply / Quality / Operations), as well as with Legal, finance and procurement business partners. Provide and communicate proactive risk assessment, with mitigation plans and/or risk acceptance when applicable. Assess and communicate on business case impacts. Define and negotiate contract management strategy with new buyers. Coordinate with EM&S teams all activities until MAT (Marketing Authorization Transfer) / effective project closure. Lead transition to EM&S operation from transaction is closed to MAT. The New Product Introduction Leader will be responsible for the management and implementation of cross-functional teams, as well as continuously improving effectiveness of the SPPM tools and processes: Provide leadership and direction to assigned project team members. Institute comprehensive work breakdown structures for all team deliverables; track and follow up on implementation of team decisions. Identify resource and schedule constraints, key risks and issues to be resolved, and proactively drive the development of contingency and/or risk mitigation plans. Ensure proper and timely communication to the relevant stakeholders, incl KPIs, meeting minutes, dashboards and management reports/presentations. Ensure the respect of project commitments (budget, milestones & deliverables). Drive decision making to the relevant stakeholders (Capex/OPEX, Sourcing, Capacity, resources, prioritization, timing). Scope
All technologies, in large and small molecules. Projects defined below are requiring expertise navigating in complex, strategic environments with either Overall project CapEx + OpEx + CMO commitments ? 15M and/or peak sales ambitions > 1B and/or Sanofi BOI contribution > 100M. About You In addition, SPPM Project Leader is expected to: Work independently under minimal supervision and direction. Participate and lead in determining objectives of significant projects or assignments. Perform work that requires decision making and the consistent exercise of independent judgment and discretion. Soft Skills
Strategic thinking: Analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focus on priorities. Able to shape a vision. Able to lead & animate networks, teams, experts - Strong communication skills Results orientation: Demonstrated ability to drive initiatives from concept to execution High level of autonomy. Executes, comfortable with ambiguity, and adapts with agility. Takes calculated risks and anticipates potential issues. People development: Engages and leverages everyone's strengths while being highly self-aware. Instore the culture of feedback & empower people to grow & manage his/her career path. Relationship & Influence: able to manage ambiguity and partners without solid reporting line Stretched ambition and take action. Encourages the teams to stretch and do things differently & creates space for the teams to take action. Commit to Patients and full product quality. Makes sure the teams understand how to act for patients and customers. Approaches the role with humility and thinks Sanofi first. Basic Requirements
Bachelor's degree in Biology/Pharma/Chemistry or other scientific discipline Minimum of 12 years' experience in technology transfer within biopharmaceutical manufacturing Strong experience in Project Management Prior experience working with external manufacturers/CMOs is strongly preferred but not required. Technical Skills
Knowledgeable in E2E product & industrial strategy, new product launches, project management Robust financial understanding Excellent communication, interpersonal skills and experience working within a matrix organization Good understanding of data management and IA digital 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