Syncromune® · 1 month ago
Associate Director, CMC Analytical Development, Separation
United States
Full-time
Remote
Lead/Staff
$165K/yr - $200K/yr
5+ years expSyncromune is a biotechnology company focused on drug development, and they are seeking an Associate Director of CMC Analytical Development. This role involves overseeing analytical strategies for drug substance and product development, ensuring compliance with regulatory standards, and leading a team in method development and validation.
BiotechnologyLife SciencePharmaceuticalTherapeutics
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
Qualification
Required
Ph.D. or M.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Must have 5+ years of pharmaceutical or biotechnology industry experience specializing in analytical development
Must have working knowledge of cGMP, ICH, and regulatory guidelines
Must have hands-on experience managing global CTLs and CDMOs
Must have strong technical expertise in separation science, such as liquid chromatography or mass spectrometry
Must have strong technical experience in at least one of the modalities: monoclonal antibody and/ or oligonucleotide
Must have 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
Preferred
Good to have experience in complex drug products, such as co-formulation, multi-components, conjugates, etc
Good to have experience in extended characterization & comparability studies to support BLA submission
Good to have experience in authoring technical and scientific documents for regulatory submissions, including IND and BLA filings
Good to have late phase experience, such as PPQ and commercialization
Candidates proficient in both English and Mandarin are highly encouraged to apply
Benefits
Cash incentive compensation
Equity incentive compensation
Employee benefits under the Company’s benefit plans
Company
Syncromune®
LEGION-100 Trial for Metastatic Prostate Cancer is Now Enrolling - Learn More: www.legion100trial.com Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class cancer immunotherapy platform designed to address major unmet needs and treatment challenges of incurable metastatic solid tumors.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$154.83M2024-12-20Series A· $144.83M
2021-04-01Seed· $10M
Leadership Team
Eamonn Hobbs
Founder, President & CEO
Recent News
2026-01-11
2026-01-07
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