M and S EM and S –SPPM – New Product Introduction Leader

Job Title: M and S EM and S –SPPM – New Product Introduction Leader

Location: Cambridge MA, Northborough, MA

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.

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

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:

New Product launches / Tech Transfer (TT) project management

• Lead project management for New Product launches/TT 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, incl

• Set-up the project team

• Define the potential targeted sourcing CMOs and coordinate Request for Quotation wit 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

BD (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, with associated

• 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

• Provides 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

• And 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.

• And 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 teams 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 I complex, strategic environments with either Overall project CapEx + OpEx + CMO commitments ≥ 15M€ and/or peak sales ambitions > 1B€ and/or Sanofi BOI contribution > 100M€.

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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

• undefined

• 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 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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