Spezialist galenische Entwicklung mit langjähriger Erfahrung (m/w/d) 100%
Core
Conducting technical trials, manufacturing test batches, and GMP-compliant charges for clinical studies and regulatory projects in a pilot plant.
Role type
Senior Galenic Development Specialist (Pharmaceutical Manufacturing)
Builds
Clinical study materials, regulatory submission batches, and validated manufacturing processes for solid dosage forms.
Domain
Pharmaceutical industry, solid dosage form manufacturing, GMP compliance.
Required skills
GMP compliance, pilot plant operations, process validation, scale-up activities, batch record management, SOP development, analytical experience, ERP system proficiency.
Preferred skills
Experience with complex solid dosage forms, night shift flexibility, cross-functional collaboration with analytical development teams.
Technologies
MS-Office, ERP systems, IPC devices, pilot plant equipment.
Responsibilities
Execute technical trials and manufacture GMP-compliant charges for clinical and regulatory projects; Operate, set up, and monitor production and IPC equipment in the pilot plant; Develop, update, and maintain manufacturing instructions and SOPs; Manage sample retention, labeling, and archiving; Ensure full GMP-compliant documentation of all manufacturing and trial steps.
Seniority
Mid-level to Senior, hands-on IC
