CMC Lead

Position summary

We are looking for a CMC lead within the CMC organization with the focus on biological drug development. 

Key Activities and Responsibilities

  • Development and execution of CMC product strategy
  • Planning and execution of related development work packages, like process and analytical development, technology transfer, non-clinical and clinical manufacturing, IND/IMPD authoring, reviewing
  • Driving consensus and timely decision making with your CMC team and external consultants
  • Providing scientific guidance in terms of technology design, innovation, industry standards and trends
  • Partnering and building relationship with CDMOs and other service providers, align on legal and statement of work details
  • Representation of CMC function within the Sotio organization and active collaboration and relationship with procurement, non-clinical / clinical research, regulatory, commercial, finance, business development, legal and program management
  • Program management including agenda, minutes, action items, dashboards, timelines, budget, goals and milestones, risk register, decision log
  • Contribution to the product target development profile, quality target product profile, pharmaceutical development plan, manufacturability and developability assessment
  • Actively driving technology and development benchmarking with industry (conferences, literature, patents)
  • Supporting the business development organization in due diligence programs

Competences, Skills and Qualification

  • Master´s or PhD degree in the life sciences, ideally in biotechnology
  • Minimum 5+ years of experience in the CMC environment, ideally with 5-8 years in the biotechnology industry
  • Solid knowledge and hands-on experience in biotechnology/pharmaceutical product development process including manufacturing process (cell line, upstream, downstream, scale-up, formulation), comparability/feasibility studies, stability studies, analytical development, Quality by Design, etc.
  • Solid experience in project management and using PM software planning tools
  • Strong leadership and communication skills (persuasive, encouraging and motivating) with authentic personality and positive intent
  • Team player, pragmatic thinking, reliable CMC partner for internal and external stakeholders
  • High degree of self-awareness, self-motivation, initiative, and attention to detail
  • High resilience and ability to independently manage job priorities
  • Excellent written and presentation skills in English

Preferred Location

  • Prague (Czech republic), in in the Sotio offices based on Tokovo building
  • Basel (Switzerland), in the Sotio offices based on the Novartis Campus

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