Specialist Galenic Development with many years of experience (m/f/d) 100%

Area of responsibility

• Independent execution of technical trials as well as production of trial mixtures and GMP-compliant batches for clinical studies and registration projects.
• Collaboration in the execution of process validations, scale-up activities and production of test and validation batches.
• Operation, setup, changeover and monitoring of production equipment as well as in-process control (IPC) devices in the Pilot Plant in compliance with GMP and safety specifications.
• Recording, maintenance and adjustment of manufacturing instructions in the ERP system according to specified specifications and release processes.
• Sampling, labeling, management and archiving of retention samples from trial, validation and GMP batches in compliance with applicable GMP requirements.
• Creation, revision and maintenance of standard operating procedures (SOPs), manufacturing instructions as well as other manufacturing-specific documentation.
• Ensuring complete and GMP-compliant documentation of all manufacturing and trial steps.
• Compliance with applicable GMP, safety, hygiene and quality regulations in the Pilot Plant.
• Collaboration with the Analytical Development team

Your profile

• Completed training as a chemical technician or pharmaceutical technician with analytical experience
• Several years of GMP experience
• Enjoyment of practical work (execution of trials)
• Sound IT skills (MS-Office)
• Good German and English skills in speaking and writing
• Initiative, commitment and willingness to learn
• Flexibility, independent way of working and resilience
• Readiness for one-week night shifts during certain project phases (per year)

Your motivation

Are you looking for new challenges in a competitive environment? And do you want to tackle them creatively and independently? Do you prefer a "get-it-done" culture and prefer to think in solutions rather than problems? What are you waiting for? We will be happy to explain our Corporate Benefits in a personal conversation!

If you have any questions, Human Resources is happy to assist you at: Tel:

j4id10405677a j4it0939a j4iy26a