Manufacturing à Grande-Bretagne

Job title : Director / Senior Director, CMC

Job Type : Full Time Permanent

Reporting to : Vice President, CMC

A cutting edge CDMO company specializing in Small and Large Molecules and advanced therapies is expanding their CMC team and seeking an experienced Director - Senior Director to lead all CMC responsibilities in Germany. This role offers the unique opportunity to play a key part in the development of the team across all three verticals. Join a team at the forefront of medical innovation and contribute to groundbreaking advancements.

Key Responsibilities :

• Lead the Analytical Development and Process Development department, managing a team of scientists and technical experts.
• Oversee method development, qualification, validation, and transfer for raw materials, intermediates, APIs, and finished products.
• Collaborate cross-functionally with Quality Control, Regulatory Affairs, and Manufacturing teams.
• Ensure analytical strategies align with ICH guidelines, EU GMP, and client-specific requirements.
• Drive technology innovation, including implementation of advanced analytical platforms (e.g., LC-MS, qPCR, spectroscopy).
• Serve as the technical lead during client audits, regulatory inspections, and project meetings.
• Develop and manage departmental budget, resource planning, and capital investment strategies.
• Mentor and develop team members, fostering a culture of scientific excellence and continuous improvement.
• Author and review technical reports, regulatory submissions, and CTD sections for IND / IMPD filings.
• Stay abreast of industry trends, regulatory changes, and emerging technologies in analytical sciences.

Requirements :

Desired Competencies :