Manager, Injectable Products

Role: The Manager, Injectable Products is a technical SME responsible for sterile injectable drug products across late-stage development, process validation, commercial manufacturing, and lifecycle management. Objectives include ensuring compliant, robust manufacturing processes for biologics and small molecules, supporting technology transfer, validation, regulatory submissions, and continuous process improvements. Responsibilities encompass providing technical leadership in formulation, filling, lyophilization, and inspection; supporting operations, investigations, and quality assurance; leading process validation and lifecycle initiatives; managing external manufacturing partners; and collaborating across functions such as Regulatory, Quality, Supply Chain, and Development. Qualifications: BS/MS in Chemical Engineering, Pharma Sciences, or related, with 8+ years in pharmaceutical/biotech manufacturing supporting sterile injectables from clinical to commercial phases; expertise in aseptic processing, validation, and regulatory compliance; proven experience in investigations, CAPAs, and inspection readiness; strong project management and cross-functional leadership skills. Preferred: advanced degrees, experience with biologics, lyophilized products, global regulatory submissions, and CMO management; PMP or Lean Six Sigma certifications advantageous. High-Value: focus on biologics and small molecules, lyophilized and liquid injectables, late-stage clinical-to-commercial lifecycle, global regulatory interactions, and sterile manufacturing processes. Work setup involves cross-functional collaboration, with emphasis on lifecycle management, quality, and compliance within a biotech development environment.