Full-Time VP Head of CMC Science & Technology

As a Vice President for Global CMC Science and Technology you will lead and manage the Global CMC, Science and Technology Department within Global Technical Operations at Sobi. CMC, Science and Technology is responsible for for overseeing all aspects of CMC development, commercial product technical lifecycle management, including process and analytical development, device and packaging development, Scale up and Tech Transfers, process and analytical technical expertise to support external manufacturing, quality operations, research and development and due diligence.You will lead a talented team of scientists and engineers, driving the development, implementation and technical and scientific management of robust and scalable manufacturing processes for our pipeline of pharmaceutical products across a wide range of technologies from small molecules to advanced Biological products. Sobi’s products are manufactured within our external network of partners and contract manufacturers and analytical labs. You will also be responsible for an in-house analytical development lab in Stockholm.You will work across all levels - strategic, tactical, and operational - making a tangible impact on Sobi´s mission and long-term success. If you are ready to take ownership, lead with vision, and drive strategic change, we want to hear from you.This position is based at our Global Headquarters in Stockholm, Sweden or Global hub in Basel, Switzerland, reporting directly to Senior Vice President, Head of Global Technical Operations.

• Lead and mentor a high performing team of scientists and engineers, fostering a culture of innovation, collaboration, and continuous improvement in accordance with the mission, visions, strategic goals and values. Secure talent development and retention and an open transparent and inspiring environment for the team.
• Develop and implement CMC strategies to support the advancement of our product pipeline from late-stage development through commercialization and the full life cycle of our products.Accountable for CMC development and ensure on-time and on-budget delivery of late stage development assets through all phases, from development activities to regulatory file review and approval.
• Accountable for continuous process, device & packaging and analytical method improvements in order to maintain compliance, improve supply robustness, increase cost effectiveness and secure sustainable supply of product to our patients world-wide. Accountable for timely and cost-effective scale up and technology transfer to support product launches, geographic expansion and manufacturing/testing site change that meets all relevant regulatory requirements and quality stanards.
• Ensure commercial product, device, process and analytical method ownership to maintain technical knowledge along the life cycle and support external manufacturing and quality with technical changes, deviations investigations, health authorities inspections and compliance reports.
• Providing CMC expertise and support to relevant CMC regulatory file sections to support regulatory filling of new product introduction and regulatory variation of registered product and analytical methods.
• Support due diligence for business development projects, assessing CMC packages, timelines, costs, risks and opportunities.
• Establishing and maintaining quality procedures within area of responsibility and ensure implementation in accordance with applicable laws, regulations and guidelines in compliance with Sobi global procedures and processes.
• Act as a key member of the Global Technical Operations Leadership Team, ensuring seamless cross-functional collaboration with cross-functional teams, including R&D, External Manufacturing, Supply Chain, Quality, Regulatory Affairs, and Clinical Development.
• Manage budgets and resources effectively to achieve project milestones and deliverables.

• Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or a related field.
• Minimum 10 years of experience in the pharmaceutical/biotech industry
• Proven strategic leadership experience with the ability to inspire and motivate a diverse and global team, extensive experience from working in an international organization and across borders.
• Extensive and in-depth knowledge about clinical & commercial manufacturing, CMC process and analytical development, CMC technical lifecycle management.
• In depth understanding of regulatory and quality requirements in relevant area
• Experience of operating CMC Science and technology activities in an outsourced environment and working closely with CMO, CDMO, CLO, understanding of outsourced pharmaceutical manufacturing business drivers.
• Exceptional problem-solving and decision-making abilities.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Analytical mindset with the ability to translate data into actionable insights and strategic recommendations.
• Excellent verbal and written communication skills in English

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