Senior CMC Project Manager - Biologics

Job Title: Senior CMC Project Manager – Biologics

Level: Can be between Manager or Senior Manager level

Location: Bavaria, Germany

About the Company:

Our client is a leading pharmaceutical company specializing in the development, manufacturing, and commercialization of high-quality biologic medicines. With a strong commitment to innovation, compliance, and global health, the company plays a key role in providing affordable and effective treatments worldwide.

Job Overview:

The Senior CMC Project Manager – Biologics will be responsible for leading and managing Chemistry, Manufacturing, and Controls (CMC) activities for biologic pharmaceutical products. This role requires extensive experience in regulatory requirements, process development, technology transfer, and lifecycle management. The ideal candidate will work cross-functionally with internal teams and external partners to ensure the timely and compliant development of high-quality biologic products.

Key Responsibilities:

• Lead and manage end-to-end CMC project activities for biologic pharmaceutical products, ensuring alignment with business objectives and regulatory requirements.
• Develop and implement CMC project plans, timelines, and risk management strategies.
• Oversee technology transfer, process optimization, and manufacturing scale-up activities in collaboration with internal teams and external contract manufacturing organizations (CMOs).
• Ensure compliance with global regulatory guidelines (e.g., EMA, FDA, ICH) and contribute to the preparation of regulatory submissions (e.g., CTD Module 3, BLAs, MAAs).
• Drive cross-functional collaboration between R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure smooth project execution.
• Manage project budgets, resource allocation, and stakeholder communication.
• Identify potential risks and develop mitigation strategies to ensure project success.
• Monitor industry trends and regulatory updates to ensure continuous compliance and innovation in CMC strategies.

Qualifications & Experience:

• Master’s or Ph.D. degree in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related field.
• Minimum of 5 years of experience in CMC project management within the biologics pharmaceutical industry.
• Strong knowledge of CMC regulatory requirements and guidelines (e.g., EMA, FDA, ICH, GMP).
• Proven experience in process development, technology transfer, and manufacturing scale-up of biologic drug products.
• Excellent project management skills, with the ability to handle multiple projects simultaneously.
• Strong analytical and problem-solving abilities.
• Effective communication and stakeholder management skills.
• Proficiency in English; German language skills are an advantage.

What We Offer:

• Competitive salary and benefits package.
• Opportunity to work with a leading pharmaceutical company at the forefront of biologic drug development.
• A dynamic and collaborative work environment with career growth opportunities.
• Flexible working arrangements and a strong emphasis on work-life balance.

If you are a highly motivated CMC professional with a passion for driving successful biologic pharmaceutical projects, we encourage you to apply for this exciting opportunity.

How to Apply:

Please submit your CV and a cover letter outlining your qualifications and experience to jake.tookey@discoverinternational.com.