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Job Description

Job Title: CMC Project Manager

Solid Line Manager: Local Head of CMC Project Excellence

Job Purpose

The CMC Project Manager is a key contributor of the CMC Project Excellence department to provide a world class performance of Sanofi CMC Project Management.

The CMC Project Manager enables the most efficient transversal collaboration within and outside of CMC, fostering and aligning efficient ways of working, providing the relevant expertise and adding value by creating synergies across CMC entities, platforms, cross functions through fundamental excellence in Project Management expertise to achieve successful and fast submission and approval in China.

The role is covering the following CMC scope:

  • CMC Project Operational Management of internal and external project portfolio as well as Mid-size Capital investment projects and Strategic initiative projects.
  • CMC Business Development Licensing and Merge & Acquisition support
  • CMC Operational Excellence (PM standards, Lean and Agile project management tools, digital tools) support

Key Accountabilities

Cross-functionally manages local CMC activities in R&D specifically related to the submission and approvals of new products in China reflecting the CMC strategy of each project, drives CMC project strategic discussions to accelerate time to submit/approval in China. Covers a portfolio of projects from early-stage development up to approval (~5 projects) with a high diversity in terms CMC technologies and development complexity.

Designs and implements standards and business processes for CMC Project Management in China in collaboration with local R&D, M&S as well as CMC global team, acts as China ambassador towards global CMC team organization to enhance understanding and management of China specificities. Deploy CMC best practices, proactively contribute to the evolution of CMC best practices and experience sharing within CMC Dev and across R&D、M&S functions, drive China CMC operational excellence.

Set up project CMC China workstream, organize and leads cross-functional CMC meetings for China submissions/approvals. Identifies and manages risks related to China-specific CMC activities, working transversally with local and global project actors. Foresee challenges & hurdles for China submission/approval. Contribute to project documents & governance meetings preparation.

Incorporate country specific requirements into project planning, 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 covering all CMC related activities at developmental stages, IND/NDA/BLA 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 etc.). Drive the execution of CMC activities in accordance with project planning, manage proactively country specific topics/risks, detect deviations from project plan, assess impact on deliverables and adjust project plan timely. Develops scenarios and provides recommendations for optimization.

Supporting project outsourcing activities in China CDMOs.

May interact with Health Authority upon request of Regulatory Affairs in collaboration with RA RegCMC by delegation of the CMC Project Leader.

CMC China specific topics refer below but not limited to the list:

China IND/NDA/BLA submission package requirement for CMC (Dossier M1/ M2/M3, specific administrative documents including JS/JX, DMF etc; Additional documents in M3, PPQ requirements, Development/manufacture forms etc.)

Contract testing. Registration testing (Documents, samples preparation, challenges/issues etc.)

ChP/DMF topics

Support Business Development Licensing-in projects. Lead (or co-lead with global) CMC/manufacturing Due Diligence teams to assess Business Development opportunities. Prepare CMC project plan including cost and resources for potential licensing products and associated risk assessment and mitigations. Coordinate contract negotiation of deals and term sheets for CMC, M&S and Quality related topics. Implementation of signed inlicensing deals.

Support transversal initiatives contributing to simplification & harmonization. Support Operational Excellence initiatives (SMS, 5S, etc)

Requirements

Education/Experience

  • PhD, master in Sciences or Engineer degree (Biology, Biotechnology, Bioengineering, Chemistry, Pharmaceutics, Analytical etc.) with at least 5 years’ experience in CMC Development.
  • Experience in managing international and/or multi-cultural teams
  • Experience in project management would be a plus.
  • Experience with Biologics project would be a plus.
  • Experience with product regulatory submission and approval would be a plus.

Technical skills & Competencies

  • Excellent knowledge in CMC development, R&D and Industrial interfaces
  • Excellent skills in Project Management
  • 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/NMPA guidelines on CMC practice is a plus.
  • Excellent English oral and written communication skills
  • Able to lead transversely a multidisciplinary & multicultural team.
  • Excellent negotiation skills

Behavioral Competencies

  • Put the interest of the organization ahead of own and those of his/her team
  • Take action and don’t wait to be told what to do
  • Act in the interest of our patients and customers
  • Good networking skills in cross-cultural environment
  • High willingness and ability to become acquainted with new fields (e.g. Drug Development, Device Development, Industrialization, Launch Readiness)
  • Ability to cooperate transversally with many partners from different part and level of the organization
  • Strong analytical skills, able to bring complicated topics down to the key points
  • Conflict-resolution, negotiation- and decision-making skills, influence and persuasion skills
  • Strategic thinking
  • Transversal leadership to pursue initiatives, change agent
  • Capacity to handle a high diversity of complex tasks in parallel
  • Self-motivated
  • Output oriented with pragmatic approach to new process implementation and problem solving
  • High ability in change management

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.

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Confirmed 4 hours ago. Posted 22 days ago.

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