Director of CMC Analytical and Characterization (Biopharmaceuticals, Remote)

Job summary

The role involves leading the CMC Analytical and Characterization team within the Manufacturing Science and Technology (MSAT) organization, focusing on supporting the development and commercialization of biologic products. The Director will oversee a specialized team, ensuring robust analytical packages for regulatory submissions and lifecycle management.

Qualifications

• Master’s degree or higher in a relevant scientific discipline (e.g., analytical chemistry, biochemistry, pharmacy, biotechnology).
• 10-15 years of industry experience in CMC for biopharmaceutical development, particularly with late-stage programs.
• Strong expertise in analytical methods and protein characterization for biologics, especially antibodies.
• Experience with regulatory submissions and interactions with global health authorities.
• At least 5-8 years of people management experience.

Responsibilities

• Lead and develop the CMC Analytical and Characterization team, including resource planning and performance management.
• Define and oversee analytical method development and lifecycle management strategies.
• Ensure regulatory-aligned characterization packages for biologic products.
• Provide technical oversight for comparability strategies and act as an internal expert on analytical expectations.
• Collaborate with Product Development and oversee technology transfer and validation activities.
• Support regulatory submissions and maintain quality systems during GMP manufacture.

Skills

• Proven leadership in a matrix-based, project-driven environment.
• Strong strategic thinking and scientific credibility.
• Ability to manage complex deliverables under pressure.
• Excellent communication skills for cross-functional collaboration.

Education

• Master’s degree or higher in a relevant scientific discipline.

Tools

• Familiarity with analytical methods and quality systems in biopharmaceutical development.