CMC Lead

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

The CMC organization has responsibility for major tasks in the life cycle of a biological drug candidate starting from research through the commercial phase:

  • Design aspects of molecules in early research phase including development and production of the protein-based drug.
  • Develop a manufacturing process and control strategy to support the clinical and commercial supply of the new medicinal product including scale up for large scale production according to ICH GMP guidelines.
  • Establishing the physicochemical properties of a new chemical or biological entity including structure function studies in support of drug potency, stability and safety.
  • Develop a drug product formulation and drug product dosage form in support of the clinical phases and commercial launch including the establishment of stability and solubility data.
  • Responsible to support regulatory filings by authoring the respective CMC chapter of the submission documents.

The CMC activities are based on science and innovation, a regulatory body of guidances and compendial monographs and industry benchmarks. Within the Sotio organization the majority of CMC activities will be executed with external partners (CDMOs, CMOs, CROs).

 

The CMC accountability includes integrated planning for CMC work-packages and sub-projects including resources, timelines, budget. Furthermore the selection of external partners, contracting, establishing the basic scope of work and design of the CMC activity, establishing and reviewing detailed executional development,  manufacturing or other study plans, monitoring of the executional phase and provide guidance for high–level process design, technology and innovation. Every project requires a risk mitigation plan, planning for acceleration scenarios and should be accompanied by a manufacturability assessment freedom to operate assessments.

The position requires strong communication skills within the various functions of Sotio related to CMC activities but also with all the CDMO and CRO partner organizations.  


 

Roles & 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

 

Desired Characteristics

  • 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

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