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 the development of biologics, particularly antibody-based therapies. The Director will shape the analytical strategy and oversee the team's efforts in supporting 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, with a focus on late-stage programs.
• Strong expertise in analytical methods and protein characterization for biologics, particularly antibodies or antibody drug conjugates.
• 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, qualification, validation, and lifecycle management strategies.
• Ensure regulatory-aligned characterization packages for the biologic pipeline.
• Provide technical oversight for comparability strategies during phase transitions and process changes.
• Collaborate with internal and external stakeholders, including CMOs, to ensure effective communication and support.
• Contribute to the preparation and review of CMC sections for global regulatory submissions.

Skills

• Proven leadership ability in a matrix-based environment.
• Strong strategic thinking with hands-on scientific credibility.
• Ability to manage multiple priorities in a fast-paced environment.
• 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.