Associate Director, CMC Analytical Development, Separation

Principal Duties and 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.
• Indirect Reports: supervise CDMO, CTL, and external resources (such as consultants)

Education

• 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.
• 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.

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: $165-$200K

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.