Senior CMC Analytical Specialist (Biotechnology, Remote)

Job summary

This role involves contributing to the advancement of a diverse biologics pipeline, focusing on antibody-based modalities such as bispecific antibodies and Antibody-Drug Conjugates (ADCs). The position is within a specialized CMC Analytical and Protein Characterization team, requiring collaboration with various stakeholders to ensure robust analytical strategies for successful development and regulatory submissions.

Qualifications

• Master’s degree in Science, Pharmacy, or a related field (PhD or additional qualifications are a plus).
• 8–10+ years of experience in CMC or a related area within the pharmaceutical or biotechnology industry.
• Strong expertise in analytical validation and characterization, particularly with biologics and small molecules, ideally from ADC projects.
• Experience with regulatory documentation and submissions (e.g., BLA, MAA).
• Excellent communication skills in English, capable of engaging effectively across functions and cultures.

Responsibilities

• Lead and oversee analytical method strategies, including development, qualification, validation, transfer, and lifecycle management.
• Establish regulatory-aligned characterization packages across the biologics pipeline.
• Provide scientific and technical oversight of analytical activities at Contract Manufacturing Organizations (CMOs).
• Collaborate on non-GMP analytical activities supporting characterization and testing strategies.
• Support analytical activities related to phase transitions, process changes, and site transfers.
• Act as a subject matter expert, guiding analytical approaches from early-stage development through commercialization.
• Drive the implementation of analytical strategies across projects.
• Author and review technical and regulatory documentation, contributing to BLA/MAA submissions.
• Work cross-functionally to enhance late-stage analytical strategies and processes.

Skills

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

Education

• Master’s degree in Science, Pharmacy, or a related field; PhD preferred.

Tools

• Familiarity with analytical methods and regulatory submission processes in the biotechnology sector.