Associate Director, CMC Analytical Development, Separation
About The Position
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 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:
Requirements
- 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.
Nice To Haves
- Experience in complex drug products, such as co-formulation, multi-components, conjugates, etc.
- Experience in extended characterization & comparability studies to support BLA submission.
- Experience in authoring technical and scientific documents for regulatory submissions, including IND and BLA filings.
- Late phase experience, such as PPQ and commercialization.
- Candidates proficient in both English and Mandarin are highly encouraged to apply.
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.
- Supervise CDMO, CTL, and external resources (such as consultants)
Benefits
- 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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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
