Your tasks

• You develop and manage the CMC strategy across the relevant development phases and translate product and approval goals into concrete technical development plans.
• You are responsible for the pharmaceutical-technical development of the active ingredient and drug, including formulation, manufacturing process, analytical control, specifications and stability program.
• You coordinate the creation and maintenance of CMC content for study and admission documents and, together with Regulatory Affairs, prepare answers to questions from authorities.
• You manage external manufacturers and development partners, especially CMOs/CDMOs, including technical coordination, project milestones, technology transfers and the follow-up of agreed actions.
• You assess technical risks to product quality, development plans and supply, and initiate appropriate measures to minimize these risks.
• You coordinate stability data, changes to manufacturing processes and testing methods, as well as the necessary assessments throughout the product lifecycle.
• You ensure that technical decisions, data and development reports are documented transparently and aligned with the relevant quality and approval requirements.
• You lead and develop the CMC Affairs team and ensure clear responsibilities, priorities and reliable cooperation.
• You regularly present progress, dependencies, risks and decision-making needs to the project teams and to management.

Your profile

• You have a completed university degree in pharmacy, chemistry, process engineering, biotechnology or a comparable scientific or technical field.
• You have several years of professional experience in management consulting or in the CMC department of a pharmaceutical or biopharmaceutical company.
• You understand the interfaces between CMC, Regulatory Affairs, Quality Assurance and clinical development, and you can translate technical questions into viable decisions.
• You can assess complex requirements in a structured way, communicate them clearly, and translate them into practical action steps.
• For the Director role, you bring demonstrable leadership and strategic management experience; for the Team Lead role, experience in professional team or project management is important.
• You work in a structured, hands-on and solution-oriented manner, keeping an eye on quality, schedule and security of supply at the same time.
• You communicate confidently in German and English and work competently with internal and external partners.
• You value initiative, short decision-making processes, transparency, and open feedback.
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