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仕事内容

Company Overview


Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com


Job Description


Reporting to the External Collaboration and CMC Operation Manager, our new CMC Project Manager will be responsible for managing CMC projects in line with the CMC Development vision and strategy.


Job Responsibilities

  • Integrate detailed execution and long-term development plans across the various CMC areas, including Drug Substance Development (NCE/NBE), Drug Product development and manufacturing, Analytical Sciences and Stability, for a portfolio of projects
  • Co-Lead CMC sub team and CMC extended Review Meeting with CMC Lead: provide concise agendas and minutes, including key decisions and actions items
  • Ensure collaboration and alignment with internal stakeholders (CMC Cross-functional Team, Regulatory Affairs, Quality Management, Strategic Marketing, Operations, Procurement, Project Management) and external partners (CDMO, CMO, Supplier)
  • Prepare global timelines and plans based on input from CMC and tracks CMC tasks and completion status
  • Provide clear directions to meet expectations of all stakeholders
  • Manage CMC-related activities related to regulatory filings, budget tracking, long range planning, purchase request, invoices, contracts, agreements, technical reports, meeting scheduling
  • 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)
  • Assist with writing/reviewing of product development documentation including technical reports, protocols, specifications, summary of technical data, or other as needed. Conduct literature searches as needed
  • Anticipate issues (technical, business, regulatory), recommends mitigation for emerging risks and consolidate budget
  • Consolidate the budget and the different action plans to ensure an effective monitoring and resource planning
  • Follow all training and guidelines established for the business, GXP and SHE requirements and complete all training in a timely fashion

Minimum Requirements
  • MSc, PhD, Pharmacist, Engineer with 5 + years of experience in chemistry, pharmaceutical sciences or closely related to the field, PMP certification
  • Experience in project management, budget preparation and analysis, setting dashboard and reporting KPIs
  • Advanced knowledge of pharmaceutical product/package development flow from ideation to product launch in a drug product and medical device environment
  • Proven track-record of successfully working in interdisciplinary teams including external partners, on multiple CMC development projects
  • Sound understanding of regulatory requirements (e.g. ICH, GMP) across the different regions
  • Practical experience demonstrated in compiling CMC documentation towards CTA/CTD/BLA
  • Excellent project integration, planning, communication, and documentation skills
  • Demonstrated ability to work in teams, to build strong relationships
  • Strong networking skills and a focus on cross functional collaboration and customer service
  • Advance knowledge of planning tools

Job Reference: 110000121
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締切: 09-05-2024

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