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:
* 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.