The Associate Director/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.
Principal Duties and Responsibilities include the following:
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.
Supervisory Responsibilities:- Indirect Reports: supervise CDMO, CTL, and external resources (such as consultants)
Qualification Requirements:
Education:- Ph.D. or M.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
Experience:
Must have 8+ 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.
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.
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.
Working Conditions:- Specify work environment:
Work from home.
Domestic and international travel up to 25%.
Regularly required to stand, sit, talk, hear, and use hands
Prolonged periods of sitting and standing
Syncromune is an Equal Opportunity Employer.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range for Assoc Director and Director levels: $165-$245K
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.
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Syncromune® is a pharmaceutical or biotechnology company that develops drug substances and drug products across clinical development and commercialization phases. The company specializes in complex therapeutics, including monoclonal antibodies and oligonucleotides, with expertise in advanced formulations such as co-formulations, multi-component products, and conjugates. Syncromune® operates a global network of contract development and manufacturing organizations (CDMOs) and contract testing laboratories (CTLs) to support their analytical development and manufacturing strategies. The company is focused on bringing innovative therapeutics to market while maintaining strict compliance with cGMP, ICH, and FDA regulatory guidelines.
