Associate Director, CMC Analytical Development, Separation

Syncromune•Fort Lauderdale, FL

2d•$165,000 - $200,000•Remote

About The Position

The Associate Director of CMC Analytical Development will oversee the execution of the analytical strategy for drug substance and drug product development across all phases of clinical development and commercialization. This role is responsible for overseeing method development, validation, transfer, and lifecycle management to ensure compliance with regulatory requirements and alignment with company objectives.

Requirements

Ph.D. or M.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
5+ years of pharmaceutical or biotechnology industry experience specializing in analytical development.
Working knowledge of cGMP, ICH, and regulatory guidelines.
Hands-on experience managing global CTLs and CDMOs.
Strong technical expertise in separation science, such as liquid chromatography or mass spectrometry.
Strong technical experience in at least one of the modalities: monoclonal antibody and/or oligonucleotide.
Experience in method development, validation, and lifecycle management for QC methods.
Ability to work in a fast-paced virtual environment.
Flexibility to travel domestically and internationally as required.
Excellent communication, leadership, organizational and project management skills.

Nice To Haves

Experience in complex drug products, such as co-formulation, multi-components, conjugates, etc.
Experience in extended characterization & comparability studies to support BLA submission.
Experience in authoring technical and scientific documents for regulatory submissions, including IND and BLA filings.
Late phase experience, such as PPQ and commercialization.
Proficient in both English and Mandarin.

Responsibilities

Define and implement analytical development strategies to support CMC programs from early development through commercialization.
Provide technical leadership in analytical sciences, including chromatography, spectroscopy, and characterization techniques.
Guide analytical development activities at CDMO and CTL, including method development, optimization, transfer, validation, troubleshooting, and lifecycle management for GMP test methods for DS and DP.
Guide extended characterizations in support of comparability and regulatory applications.
Foster collaboration with cross-functional groups including Process Development, Quality, and Regulatory Affairs.
Author and review analytical sections of regulatory submissions (IND, IMPD, NDA, BLA).
Ensure adherence to GMP, ICH, and FDA guidelines for analytical activities.
Drive continuous improvement and innovation in analytical technologies and processes.