Director of CMC

Skills Alliance; Berlin; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading CDMO company in Berlin is seeking an experienced Director / Senior Director to lead their CMC responsibilities. This role involves managing a team of scientists, overseeing method development, and ensuring compliance with regulations. The ideal candidate should have a PhD or MSc in Analytical Chemistry or related fields, with over 10 years of experience in analytical development and proven leadership skills. Fluency in German and English is required.

Qualifikationen

• 10+ years in analytical development in a CDMO or pharma/biotech setting.
• 4+ years in process development within a CDMO setting.
• Proven leadership and team-building experience.

Aufgaben

• Lead Analytical Development and Process Development departments.
• Oversee method development, qualification, and transfer.
• Collaborate with Quality Control, Regulatory Affairs, and Manufacturing teams.

Kenntnisse

Analytical development

Process development

Leadership

Problem-solving

Communication (German and English)

Ausbildung

PhD or MSc in Analytical Chemistry, Biochemistry, or Pharmaceutical Sciences

Tools

LC-MS

qPCR

Spectroscopy

Jobbeschreibung

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.