Associate Director, Biologics Analytical Development

Celcuity Inc.; Alameda (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Celcuity (SAB) is seeking an experienced leader to direct Analytical Development & QC in support of biologic drug development. The role focuses on method development, validation, and QC oversight at CDMOs/CROs for antibody-derived modalities, with emphasis on regulatory readiness.

The candidate will lead cross-functional teams, write technical regulatory documents (IND/IMPD/CTA), and ensure compliance with ICH guidelines while building a high-performing, collaborative group in a fast-paced

Qualifications

• Proven track record supporting preclinical and clinical stage antibody-derived modalities.
• Analytical development in drug substance and drug product with specs, methods, and control strategies.
• Deep knowledge of analytical techniques: HPLC, CE, LC-MS, ELISA, qPCR, spectrophotometry.
• Strong understanding of ICH and industry guidelines for method development, qualification, transfer.
• Experience drafting regulatory documents for IND/IMPD/CTA submissions.
• Proven leadership of cross-functional teams and project management.
• Excellent written/verbal communication, collaboration, and organization.
• Team-oriented, execution-focused, in fast-paced environments that require agility.

Responsibilities

• Provide technical leadership for CMC analytical activities at CDMOs/CROs.
• Lead method development, qualification, and validation for batch release, stability, and characterization.
• Serve as liaison between analytical development, research, process development, QA, and manufacturing.
• Contribute to regulatory discussions and IND/IMPD/CTA preparations with regulators.
• Prepare/approve technical documents, SOPs, CoTs/CoAs, and investigation reports.
• Collaborate with QA/CMC, review methods and data, support nonconformance investigations.
• Identify and manage CDMO/vendor relationships and scope of work negotiations.
• Monitor KPIs to optimize laboratory quality and productivity.

Skills

Analytical development

CDMO management

HPLC

LC-MS

ELISA

qPCR

Regulatory writing

Project leadership

Communication

Education

PhD or MS in Pharmaceutics/ Chemistry/ Chemical Engineering

Job description

Celcuity (SAB) is seeking an experienced leader to direct Analytical Development & QC in support of biologic drug development. The role focuses on method development, validation, and QC oversight at CDMOs/CROs for antibody-derived modalities, with emphasis on regulatory readiness.

The candidate will lead cross-functional teams, write technical regulatory documents (IND/IMPD/CTA), and ensure compliance with ICH guidelines while building a high-performing, collaborative group in a fast-paced