Overview 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. 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 PhD or MSc in Analytical Chemistry, Biochemistry, or Pharmaceutical Sciences 10+ years in analytical development, ideally within a CDMO or pharma / biotech setting 4+ years in process development, ideally within a CDMO setting Proven leadership and team-building experience Deep expertise in GMP, ICH guidelines, and regulatory expectations Strong communication skills in German and English Desired Competencies Hands-on approach with strong problem-solving skills. Ability to work independently as well as collaboratively in a dynamic environment. Experience with regulatory submissions is a plus. #J-18808-Ljbffr