Associate Director/Director, CMC Analytical Development, Separation

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the implementation of the analytical strategy for the development of drug substances and drug products.

• Define and execute analytical development strategies that support CMC programs.

• Provide technical direction in analytical sciences, encompassing chromatography, spectroscopy, and characterization techniques.

• Guide analytical development initiatives at CDMO and CTL, which includes method development, optimization, transfer, validation, and troubleshooting.

• Promote collaboration with cross-functional teams, including Process Development, Quality, and Regulatory Affairs.

• Author and review the analytical sections of regulatory submissions such as IND, IMPD, NDA, and BLA.

• Ensure compliance with GMP, ICH, and FDA standards for analytical activities.

• Champion continuous improvement and innovation in analytical technologies and methodologies.

⛳️ Requirements

• Ph.D. or M.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related discipline.

• Over 8 years of experience in the pharmaceutical or biotechnology industry, with a focus on analytical development.

• Working knowledge of cGMP, ICH, and other regulatory guidelines.

• Practical experience in managing global CTLs and CDMOs.

• Strong technical proficiency in separation science, including liquid chromatography and mass spectrometry.

• Significant technical experience in at least one modality: monoclonal antibodies and/or oligonucleotides.

• Experience in method development, validation, and lifecycle management for QC methods.

• Preferable experience with complex drug products, such as co-formulations, multi-components, and conjugates.

• Preferable experience in extended characterization and comparability studies to support BLA submissions.

• Preferable experience in authoring technical and scientific documents for regulatory submissions, including IND and BLA filings.

• Preferable late-phase experience, including PPQ and commercialization.

• Proficiency in both English and Mandarin is highly encouraged to apply.

🏝️ Benefits

• Cash incentive compensation

• Equity incentive compensation

• Employee benefits under the Company’s benefit plans