Director of CMC

Stellenbeschreibung:

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.