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€.
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
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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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$148,125.00 - $213,958.33All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.