Senior Analytical Life Cycle Management Specialist

Job summary

This role involves contributing to antibody-based modalities lifecycle management projects, specifically focusing on Bispecific Antibodies and Antibody-Drug Conjugates (ADCs). The position requires collaboration with various stakeholders in a highly specialized CMC Analytical and Protein Characterization department, ensuring robust analytical oversight for regulatory submissions and lifecycle management.

Qualifications

• Master’s degree in Science, Pharmacy, or a related field (PhD or additional qualifications are a plus).
• Over 7 years of experience in CMC or a related area within the pharmaceutical or biotechnology industry.
• Strong expertise in analytical lifecycle management, particularly in quality control.
• Experience with biologics, especially Antibodies and ADC projects.
• Proficient in authoring and reviewing regulatory documentation and submissions (e.g., BLA, MAA).
• Familiarity with working with Contract Manufacturing Organizations (CMOs) in a late-stage or lifecycle management context.
• Excellent communication skills in English, capable of engaging across functions and cultures.

Responsibilities

• Lead lifecycle management activities, including analytical method qualification, validation, and transfer.
• Provide scientific and technical oversight of analytical activities at CMOs, including quality event evaluations.
• Support analytical activities related to process changes and site transfers.
• Author and review technical and regulatory documentation for submissions and health authority responses.
• Serve as a subject matter expert, guiding analytical strategies from late development through commercialization.
• Collaborate with CMC MSAT colleagues, regulatory CMC, QA, project managers, and QC to align activities for late development and commercial projects.
• Develop and enhance lifecycle management strategies and processes across projects.

Skills

• Strong analytical and problem-solving skills.
• Ability to work collaboratively in a team-oriented environment.
• Innovative mindset with a focus on precision and excellence.

Education

• Master’s degree in Science, Pharmacy, or a related field (PhD or additional qualifications are an advantage).

Tools

• Familiarity with analytical methods and regulatory submission processes.