Global Program Manager CMC

To join one of our prestigious client, a growing international pharmaceutical company with strong portfolio in large and small molecule, We are currently looking for a Global Program Manager CMC to lead all CMC operations and projects portfolio. You will be providing methodology and project management expertise throughout the cross-functional CMC Team. In addition, you will be responsible for the overall management of the CMC projects and quality documentation. The position is based near Lausanne or Zurich or can have some remote flexibility within Switzerland.

Your Responsibilities

  • Global consolidation of CMC drug development (early to late stage, NCE / NBE), life cycle management and maintenance projects to establish and maintain the CMC projects portfolio
  • Ensure project plans and objectives are clearly established and communicated. Create global timelines and utilize planning tools (e.g. visual planning) such as decision support models and Gantt charts
  • Oversee product design and development projects plan and execution: activities, milestones, costs and risks
  • Ensure timely and effective communication. Report via written communication as well as presentations, discussions and informal interactions. Track progress, communicate early warnings on risk(s), budget variance(s) and project delay(s)
  • Develop and maintain a visual dashboard and provide relevant key performance indicators
  • Act as single point of contact of Finance and Strategic Management to create purchase orders, invoice tracking/payments, accruals and reforecasting on a monthly basis, in close cooperation with CMC cross-functional Team
  • Coordinate yearly and 3Y CMC budget plan, and contribute to the rolling forecast update (External Costs and Internal Costs - OPEX)
  • Manage the CMC Project Management Office and Documentation team to support short, mid and long-term strategy and Develop a vision for the team
  • Organize CMC Team meetings (e.g. Team Meeting, Technical Project Review, Budget Review); provide concise agendas and minutes, including key decisions and actions items
  • Consolidate at the Department level the different action plans to ensure an effective monitoring and resource planning
  • Provide best project management practices across the CMC Development Department
  • Act as continuous improvement champion, by providing support and methodology when assessing, improving or defining business processes
  • Organize and lead documentation management within the Department ensuring availability and storage of CMC source documents
  • Follow all training and guidelines established for the business, GXP and SHE requirements and complete all training in a timely fashion

Your Profile

  • Proven experience in project and portfolio management, budget preparation and analysis, setting dashboard and reporting KPIs
  • MS or PhD combined with a minimum of 10 years of experience in chemistry, pharmaceutical sciences or closely related to the field, PMP certification
  • Advanced knowledge of pharmaceutical product/package development flow from ideation to product launch in a drug product and medical device environment. Sound understanding of regulatory requirements (e.g. ICH, GMP) across the different regions
  • Practical experience demonstrated in compiling CMC documentation, in particular related to module CTA/CTD/BLA
  • Excellent project integration, planning, communication and documentation skills. Advanced knowledge of planning tools (Microsoft Project, Excel, PowerPoint and Outlook)
  • Proven track-record of successfully working in interdisciplinary teams on multiple CMC development projects
  • Demonstrated ability to work in teams, to build strong relationships
  • Strong networking skills and a focus on cross functional collaboration and customer service

For more information, feel free to contact : Noémie Oliva: noliva@axepta.com

Noémie OLIVA

Noémie OLIVA

Team leader & Recruitment Manager Life Sciences

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Global Program Manager CMC

Sep 15, 2021Global Program Manager CMCHome Office Lausanne Full Time Permanent Job noliva@axepta.com Life Sciences

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