Associate Director, CMC Analytical Development – Separation

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

📋 Description

• Manage the implementation of the analytical strategy for drug substance and drug product development throughout all stages of clinical development and commercialization.

• Supervise method development, validation, transfer, and lifecycle management to ensure adherence to regulatory standards and alignment with organizational goals.

• Establish and execute analytical development strategies to support CMC programs from the initial stages through to commercialization.

• Provide expert technical guidance in analytical sciences, including chromatography, spectroscopy, and characterization techniques.

• Direct analytical development initiatives at CDMO and CTL, covering method development, optimization, transfer, validation, troubleshooting, and lifecycle management for GMP test methods for DS and DP.

• Oversee extended characterizations to support comparability and regulatory submissions.

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

• Draft and review analytical sections of regulatory submissions (IND, IMPD, NDA, BLA).

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

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

• Manage CDMO, CTL, and external resources, including consultants.

⛳️ Requirements

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

• 5+ years of experience in the pharmaceutical or biotechnology industry focused on analytical development.

• Comprehensive knowledge of cGMP, ICH, and regulatory guidelines.

• Practical experience in managing global CTLs and CDMOs.

• Strong technical skills in separation science, including liquid chromatography or mass spectrometry.

• Extensive technical experience in at least one of the following modalities: monoclonal antibody and/or oligonucleotide.

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

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

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

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

• Preferred late-phase experience, such as PPQ and commercialization.

• Candidates who are proficient in both English and Mandarin are strongly encouraged to apply.

• Ability to thrive in a fast-paced virtual environment.

• Willingness to travel domestically and internationally as needed.

🏝️ Benefits

• Cash incentive compensation

• Equity incentive compensation

• Employee benefits under the Company’s benefit plans