CMC Project Leader (m/f/d) 100%

Shape the Future of Biologics Development in a Leading Pharmaceutical Environment

• Duration: ASAP - 24-month contract
• Location: Basel, Switzerland
• Type: Temporary Assignment
• Slaray range: CHF 70,-/h - 93,-/h

About Our Client

For our client, a globally renowned pharmaceutical corporation headquartered in Basel, we are seeking an exceptional Drug Product Project Leader (m/w/d). This industry-leading organization is at the forefront of biologics innovation and represents one of the world's largest pharmaceutical companies by market capitalization. As a key player in the Basel pharmaceutical hub - home to over two-thirds of Switzerland's pharmaceutical value-added - our client drives breakthrough medical innovations that transform patients' lives worldwide.

Your Mission

• Strategic Leadership: Drive complex Drug Product Development initiatives within biologics projects, serving as the primary interface between cross-functional teams and CMC leadership •
• Global Team Coordination: Orchestrate international drug product sub-teams encompassing formulation scientists, process development experts, analytics specialists, production teams, and regulatory professionals • Scientific Excellence: Ensure rigorous adherence to scientific review processes while authoring and reviewing critical development documents for robust CMC submission packages 
• Regulatory Expertise: Lead the creation of regulatory CMC documentation, contribute to filing dossiers, and provide expert support during health authority inspections and requests 
• Resource Management: Oversee comprehensive budget planning and resource allocation for both internal and external drug product development activities 
• Innovation Leadership: Spearhead key scientific initiatives to establish short and long-term development strategies for extensive NBE pipelines 
• Mentorship: Guide junior scientists and project leaders globally, fostering scientific excellence and project management capabilities throughout the organization 
• External Representation: Present scientific findings at international conferences, participate in industry consortiums, and contribute to peer-reviewed publications

Your Profile

• Advanced Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent scientific discipline 
• Industry Experience: Minimum 5 years of proven success in biotech/pharmaceutical industry with specialized focus on biologics drug product development 
• Technical Expertise: Comprehensive knowledge in formulation and process development, manufacturing scale-up, and technology transfer for biologics 
• Regulatory Knowledge: Experience with protein analytics, lyophilization, primary packaging development, and BLA/MAA submissions highly advantageous 
• Leadership Excellence: Demonstrated track record in resolving complex technical challenges and leading strategic innovation projects to successful completion 
• Cross-functional Collaboration: Outstanding ability to work effectively in international, interdisciplinary teams with proven scientific leadership capabilities 
• Project Management: Strong competencies in managing complex projects within matrix organizations, coupled with excellent communication and negotiation skills 
• Communication Skills: Exceptional presentation abilities and scientific/technical writing expertise for both internal and external stakeholders

Advantages Nemensis

• Nemensis AG is your specialized personnel consultant in the Life Sciences sector with headquarters in Basel 
• Comprehensive consultation and support throughout the application process by our experienced consultants 
• Access to an extensive client network and exciting positions in Northwestern Switzerland 
• Fast and uncomplicated entry through individual guidance and consultation in the application process

Ready to Advance Your Career in Pharmaceutical Innovation?

At nemensis ag, we have successfully connected thousands of professionals with their dream jobs, providing opportunities for career advancement and market re-entry. What can we do for your career today? Contact us and discover how this Drug Product Project Leader (m/w/d) position in Basel could be your next career milestone!