Director of CMC

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

Zusammenfassung

A leading pharmaceutical company in Germany seeks a Director/Senior Director, CMC to lead all CMC responsibilities. The role involves driving analytical development and managing a team of scientists in a cutting-edge CDMO environment. Candidates should have over 10 years of experience in the field, a PhD or MSc in a relevant area, and strong skills in leadership and process development.

Qualifikationen

• 10+ years in analytical development, ideally within a CDMO or pharma/biotech setting.
• 4+ years in process development, ideally within a CDMO setting.
• Deep expertise in GMP, ICH guidelines, and regulatory expectations.

Aufgaben

• Lead the Analytical Development and Process Development department.
• Oversee method development, qualification, validation, and transfer.
• Drive technology innovation, including advanced analytical platforms.

Kenntnisse

Leadership

Analytical Development

Process Development

Strong communication skills

Ausbildung

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

Jobbeschreibung

Director/Senior Director, CMC role description and overview is provided below.

Senior Business Manager - Global CDMO Specialist

Overview

Senior-level position leading all CMC responsibilities in Germany within a cutting-edge CDMO company specializing in Small and Large Molecules and advanced therapies. This role offers the opportunity to contribute to the development of the CMC team across three verticals and participate in groundbreaking medical innovations.

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.

Seniority level

• Director

Employment type

• Full-time

Job function

• Manufacturing

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing