Director of CMC 

Introduction & Purpose

This position is created to support a technical operations culture that promotes excellence through an unwavering commitment to quality, compliance, respect for people, and patient welfare.

The primary responsibility of the Director of CMC is to lead the development and implementation of CMC strategies. This includes responsibility for the manufacturing of clinical and commercial products, collaboration with contract manufacturing organizations (CMOs), materials management, distribution, and long-term planning. The role also ensures that manufacturing, CMC, supply chain, and Quality Management Systems (QMS) align with the company’s overall strategic objectives.

Responsibilities & Tasks

As Director of CMC, your responsibilities will include but are not limited to:

• Developing Technical Operations strategies for both early and late-phase drug development in collaboration with research, clinical development, finance, and business development.

• Defining short-term and long-term strategies for manufacturing, materials management, CMC, and QMS.

• Representing the company in meetings with external partners to ensure the highest standards in manufacturing, facilities, and supply chain.

• Managing development, production, technology transfer, and validation projects across multiple CMOs.

• Supporting supply chain management, distribution, and planning.

• Contributing to internal cGMP Quality Systems.

• Ensuring cGMP quality oversight at CMOs.

• Acting as the lead and technical author for all CMC regulatory documents (IND, IMPD, NDA, etc.).

• Managing the budget for the Technical Operations department.

• Collaborating with other departments (Regulatory, Research, Clinical Operations, Finance, HR, etc.) to ensure corporate goals are aligned.

• Managing CMC, analytical, and quality specialists/consultants.

Qualifications & Experience

To succeed in this role, a minimum of 12 years of experience in regulated cGMP environments within the biotech, pharmaceutical, or biopharmaceutical industry is required. Relevant experiences and competencies include:

• Education: BS/MS/PhD in Chemical Engineering, Chemistry, or a related field.

• Experience in leading CMC and manufacturing activities.

• Development of systems for technology transfer and phase-appropriate production of pharmaceuticals and biopharmaceuticals.

• Experience with small and large molecules, sterile processes, filling, and packaging.

• Development and maintenance of CMC and manufacturing programs.

• In-depth experience with CDER.

• Experience from both large and small companies.

• Ability to identify and resolve Technical Operations challenges early in the development cycle.

• Strong knowledge of dosage development and manufacturing across multiple platforms (especially oral solid dose).

• Extensive understanding of cGMP, GLP, and GCP regulations.

• Excellent written and verbal communication skills.

Additional Comments

The role requires an analytical and strategic mindset, combined with a practical and action-oriented approach. We are looking for a team player who:

• Can foster a collaborative culture across departments.

• Has the ability to develop long-term strategies for Technical Operations that align with the company’s business goals.

• Can adapt to changes and navigate a fast-evolving landscape.

• Demonstrates integrity and transparency, ensuring that Technical Operations plays a key role in corporate decision-making.

• Is passionate about patient-centered innovation, where quality and compliance remain a top priority.

Travel Requirements: Minimal travel is expected in connection with collaboration with external partners and CMOs.