Associate Director/Director Pharmaceutical Development

Role: Lead CMC formulation and manufacturing development for biopharma products, supporting rapid registration and regulatory submissions. Responsibilities: provide strategic guidance, develop formulations for pediatric indications, review external development and manufacturing programs to ensure compliance, manage drug forecasts and related transactions, and collaborate with CMC teams and CDMOs. Requirements: PhD or advanced degree in Chemistry or Pharmacy; 7+ years in biopharma formulation development, clinical supply, and CMC regulatory compliance for US/EU; hands-on experience with clinical trial manufacturing, PK/PD, ADME, and regulatory documentation. Preferred: expertise in pediatric formulations, import/export sensitivities, and knowledge of commercial manufacturing. High-Value: remote work with 30% travel, focus on rare disease, clinical development stage, CMC regulatory expertise, and cross-functional collaboration in fast-paced environments.