Sanofi

R&D -CMC Project Manager -Shanghai (BB-952AB)

Found in: Neuvoo CN

Description:

Job Description :


Who we are?
As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey . We are focused on empowering our people to be agents of change , because the work we do will change health outcomes and empower patients' lives. This is where you will have access to a broad track for all-round development t as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally .
Why start your career path in Sanofi?
In here, you can:
- Join an insiring team, cooperate with brilliant people across the business and experience digital & innovative ways of working.
- Have unlimited opportunities for career growth and development within a global organization.
- Have broad presence and resources within healthcare ecosystem to help you establish and expand your own network and connections.
What you can contribute?
In the frame of global CMC project management organization, drive the planning and execution of country specific CMC activities to support regulatory submissions and readiness for launch as part of Sanofi global simultaneous Development and launch efforts.
Broad transversal project management, interact with many stakeholders across multiple functions/countries/sites, need to work across cultures, need to manage country specific activities (in 100K – 1M euros range) to support new product portfolio.
Plan and manage CMC activities to support new product submissions and registrations in China & Japan as part of global simultaneous development:
  • Support industrial sourcing case preparation, submission and approval for the country.
  • Incorporate country specific requirements into development stage gates, align with global CMC project leaders on project strategy, plan, timelines, resources, costs, risk management and mitigation plan
  • Build end-to-end CMC plans for China/Japan covering all CMC related activities at developmental stages, CTW/CTA/NDA submissions and regulatory approvals and ensure integration of activities across functions including R&D CMC platforms, RA, Reg-CMC, Clinical/Commercial Supply Chain and production and testing sites (including CMOs, alliance etc.).
  • Drive the execution of CMC activities in accordance with China/Japan project plan, manage proactively country specific topics/sensitivities/risks, detect deviations from project plan, assess impact on deliverables and adjust project plan timely.
  • China & Japan country specific CMC activities may include clinical supply planning and management, implementation of new excipients or device for CN/JP market, additional studies to demonstrate process/method comparability, ChP compliance gap analysis and risk mitigation, CMC submission package readiness, test method transfers and registration QC testing etc.
  • Provide updates/reporting on country CMC plan status to global CMC PPM, CMC leaders and CMC platforms, and to local key stakeholders.
  • Ensure appropriate stakeholder management in China/Japan when CMC activities are on critical path. These stakeholders include RA, Reg CMC, R&D, Japan IA site, BU, and/or CMO when relevant. Facilitate communications between local and global functions, minimize barriers due to differences in mindset, processes or way of working.
  • Ensure deployment of CMC PPM methodology and best practices, promote cross-fertilization between projects, strive for execution excellence, establish sustainable business processes to support CMC activities.

Serve as in-country CMC support and liaison for all global CMC technology platforms in their in-sourcing, out-sourcing, and external collaborative CMC development activities involving China/Japan:
  • Participate in preliminary identification, support CMC assessment, Due Diligence and selection of partnership/CMO/CRO/CDMO/contract labs etc. in supporting the strategy, need and ambition of global CMC technology platforms.
  • Serve as in-country representative of global CMC platforms, provide project management and technical support where necessary, facilitate communications between global CMC platforms and external partners.

What you should have?
  • PharmD or MS degrees in chemical/biochemical engineering, biotechnology, microbiology or chemistry
  • 10+ years' experiences in CMC field such as pharmaceutical/biopharmaceutical drug development, manufacturing, quality or other industrial operation areas.
  • Well-rounded knowledge in flows/sequence and contents of CMC activities and regulatory requirements along product development and life cycle management
  • Good knowledge and understanding of ICH/FDA guidelines on CMC practice
  • Good experiences and skills in project management, able to plan both broadly and vertically covering multiple layer activities across functions aiming at achieving the ultimate goals.
  • Experienced in risk management (anticipation, identification, assessment, mitigation), able to make sound judgement in assessing impact of risks on deliverables, project plan and timelines.
  • Well-developed communication and negotiation skills, ease in working under a transversal matrix organization setting, able to work effectively across functions/countries/sites and cultures
  • Equipped with strategic, critical thinking skills, structured and organized, good analytical skills, Able to understand and transform CMC project activities, deliverables and milestones into a solid project plan, able to articulate and break down complex subjects into executable action plans
  • Result driven, pragmatic in problem solving, strong ownership in face of issues
  • Excellent presentation skills with good control of level of details required for various audience groups
  • High willingness, curiousity and ability to learn new things, such as tools/technology/practice related to product, technology, regulations, processes etc.

If you are a person demonstrate respect, teamwork, courage and intergrity with special focus on below competency:.
  • Act for change
  • Cooperate transversally
  • Drive for results
  • Develop self/develop others

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

calendar_today1 hour ago

Similar jobs

location_onChina

work Sanofi

Apply:
I expressly authorise the Terms and Conditions