Associate Director, Pharma Development & CDMO Leadership

Celcuity; United States; On-site; USD 180,000 - 210,000; Full time

Benefits offered by this job

Annual incentive bonus

Equity package

Medical insurance

Dental insurance

Job summary

Celcuity is seeking an Associate Director/Director of Pharmaceutical Development to lead formulation technology transfers, scale-up, and manufacturing processes, serving as the primary technical liaison with CDMOs. The role emphasizes vendor governance, technology transfer, and outsourced operations, supporting regulatory submissions for global filings.

Responsibilities include overseeing CDMO partners, preparing CMC documentation, and collaborating with cross-functional teams to ensure robust

Qualifications

• Ph.D./Master's or Bachelor's in chemistry or related field.
• 8+ years small molecule drug product development.
• 3+ years directly managing small molecule CDMOs for scale-up.
• Understanding of ICH guidelines (Q1-Q11), cGMP, and QbD principles.

Responsibilities

• Direct late-stage drug product design, scale-up, and manufacturing robustness using QbD.
• Oversee external CDMOs for clinical, process validation and commercial batches.
• Author/review CMC documents for global filings (IND, IMPD, NDA, MAA).
• Partner with analytical development, supply chain, quality assurance, and clinical operations in a matrixed team.

Skills

Strong communication

Vendor governance

Regulatory knowledge

Education

PhD / Master's / Bachelor's in Chemistry/Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering

Job description

Celcuity is seeking an Associate Director/Director of Pharmaceutical Development to lead formulation technology transfers, scale-up, and manufacturing processes, serving as the primary technical liaison with CDMOs. The role emphasizes vendor governance, technology transfer, and outsourced operations, supporting regulatory submissions for global filings.

Responsibilities include overseeing CDMO partners, preparing CMC documentation, and collaborating with cross-functional teams to ensure robust