CMC Lead

Position summary

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

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

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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