Associate Director of CMC Analytical Development, Potency
Syncromune®, Fort Lauderdale, FL, United States
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.
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 binding and cell-based assays and bioanalytical 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 Bioanalytical Chemistry, Cell Biology, Biochemistry, or a related field
Experience
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 biological methods, such as cell‑based potency, SPR, MSD, ELISA
Must have strong technical experience in at least one modality: 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
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: $165,000-200,000
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.
#remote
#J-18808-Ljbffr
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 binding and cell-based assays and bioanalytical 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 Bioanalytical Chemistry, Cell Biology, Biochemistry, or a related field
Experience
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 biological methods, such as cell‑based potency, SPR, MSD, ELISA
Must have strong technical experience in at least one modality: 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
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: $165,000-200,000
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.
#remote
#J-18808-Ljbffr