Key Responsibilities:
1. Strategic Technical Leadership
. Process Design & Scale-up: Lead the design and execution of scale-up strategies for diverse dosage forms (e.g., solid orals, sterile injectables, nasal spray or topicals) using Quality by Design (QbD) principles.
. Tech Transfer Ownership: Serve as the primary technical point of contact for clients, ensuring the seamless transfer of 'Sending Unit' (Client) processes to the 'Receiving Unit' (CDMO).
. Troubleshooting: Act as the ultimate Subject Matter Expert (SME) for complex formulation challenges, deviations, and 'out of specification' (OOS) investigations during the transfer phase.
2. Operational Excellence
. Facility Fit & Gap Analysis: Conduct technical assessments of incoming client processes against existing site equipment and capabilities identify and procure necessary capital equipment.
. Documentation Oversight: Review and approve Tech Transfer Protocols, Master Batch Records (MBRs), Process Validat...