Senior Project Manager CMC (w/m/d) (PR-34108850)

Our client is a developing and manufacturing biotech company near Stuttgart. To support and lead the existing project team we are currently seeking you for the position of:

Senior CMC Project Manager (m/f/d)

Your responsibilities will include:

• Independent planning, organization, and management of CMC activities within global development projects, such as process transfers, method and process validations, and IMP manufacturing.
• Managing projects for the development of biotechnological processes and associated analytics, including the creation of dossiers for the approval of clinical trial samples and market products.
• Coordinating a CMC sub-team and representing the CMC organization in interdisciplinary project teams for product and/or technology development.
• Creating project plans, monitoring project progress, risk management, and reporting to decision-making bodies.
• Developing and monitoring project budgets.
• Coordinating the creation and tracking of validation concepts, transfer plans, and risk assessments.
• Acting as the primary contact for external stakeholders regarding manufacturing and quality systems.

Knowledge, Experience & Skills:

• Completed university degree in biology, biotechnology, pharmacy, or a comparable qualification.
• Several years of experience in the development, approval, manufacturing, or quality control of pharmaceutical forms and clinical trial samples - ideally experience in the biotechnology or pharmaceutical industry.
• Profound knowledge of relevant ICH and GMP guidelines.
• Enjoyment of taking responsibility with a can-do mentality.
• Strong planning and organizational skills, teamwork, and assertiveness.
• Excellentcommunicationskillsand a structured, solution-orientedapproach
• Proficient use of MS Office.
• Fluent English skills; knowledge of German is advantageous

Your next step:

If this role would be interesting for you ill be happy to share all the background information with you. The person responsible will be Max Rudek +49 89 5519 7825