Remote: Senior Director, CMC Analytical Development

Syncromune; Fort Lauderdale (FL); On-site; USD 165,000 - 245,000; Full time

Benefits offered by this job

Cash incentive plan

Equity incentives

Employee benefits

Job summary

Syncromune seeks an Associate Director/Director of CMC Analytical Development to lead analytical strategy for DS/DP across development stages and commercialization. You will oversee method development, transfer, and lifecycle management to meet regulatory requirements and company goals.

You will guide CDMO/CTL activities, author regulatory sections, and drive GMP compliance while pushing innovation in analytical technologies.

Qualifications

• 8+ years in analytical development
• Knowledge of cGMP, ICH and regulatory guidelines
• Experience managing global CTLs and CDMOs
• Strong expertise in separation science (LC/MS)
• Experience with monoclonal antibody and/or oligonucleotide modalities
• Method development, validation and lifecycle management for QC methods
• Experience with complex drug products and comparability studies
• Experience drafting regulatory documents (IND/BLA)
• Late-phase experience (PPQ and commercialization)
• Ability to work in a fast-paced virtual environment
• Willingness to travel domestically and internationally (25%)
• Excellent communication, leadership, organizational and project management skills

Responsibilities

• Define and implement analytical development strategies for CMC from early to commercialization
• Provide technical leadership in analytical sciences (chromatography, spectroscopy)
• Guide development activities at CDMO/CTL including transfer, validation and lifecycle management
• Support extended characterizations for regulatory applications
• Collaborate with Process Development, Quality, Regulatory Affairs
• Author/review analytical sections of IND, IMPD, NDA/BLA submissions
• Ensure GMP, ICH, FDA guideline compliance for analytical activities
• Drive continuous improvement and adoption of new analytical technologies

Skills

Analytical development

Regulatory understanding

Leadership

Project management

Communication

Travel readiness

Education

PhD or MS in Analytical Chemistry or related field

Tools

Liquid chromatography (LC)

Mass spectrometry

Job description

Syncromune seeks an Associate Director/Director of CMC Analytical Development to lead analytical strategy for DS/DP across development stages and commercialization. You will oversee method development, transfer, and lifecycle management to meet regulatory requirements and company goals.

You will guide CDMO/CTL activities, author regulatory sections, and drive GMP compliance while pushing innovation in analytical technologies.