GMP/ PD Manufacturing Technician (m/w/d)

Lean Manufacturing • Hand Tools • Basic Math • Math • Mechanical Knowledge • Assembly Experience • Computer Literacy • Schematics • cGMP • Clamp Truck • Programmable Logic Controllers • Manufacturing

Lean Manufacturing • Hand Tools • Basic Math • Math • Mechanical Knowledge • Assembly Experience • Computer Literacy • Schematics • cGMP • Clamp Truck • Programmable Logic Controllers • Manufacturing

Are you a Laboratory Technician with a Bachelor's degree and a minimum of 1 year of experience working in the pharmaceutical industry in a GMP environment? Then you should keep reading!

Tasks

• Responsible for the day-to-day operation and manufacturing of RPE ATMPs in a cell-therapy GMP Grade A/B cleanroom environment according to protocols and cGMP
• Maintain batch and other production records to comply with cGMP and internal SOPs. Perform routine operation and inspection in accordance with instructions
• Efficient diagnosis of problems of non-conformances and deviations during GMP manufacture and reporting of safety incidents or hazards to supervisors.
• Support in Process Development Projects with emphasis on cell-therapy PSC-derived early phase in collaboration with the Lead of Process Development (PD). Technical transfer of new ATMPs to GMP manufacture and contribution to the continuous improvement at Tenpoint
• Maintain a clean and orderly laboratory

Requirements

• Bachelor's degree BSc or equivalent education in the field of Biological Sciences, Biomedical Engineering or related discipline
• Minimum of 1 year of experience working in the Industry in a Laboratory within a GMP environment, with good knowledge of QMS and cGMP in compliance with EU GMP/EMA/ICH and experience of aseptic cell cultures is a must
• Excellent aseptic processing and experience in cell culture is a must
• Technical proficiency that enables effective execution of documented procedures with strong attention to detail required
• Demonstrated experience with common computer software packages (Windows, MS Office)
• Positive attitude and self-motivated person willing to go the extra mile, good communication and problem-solving abilities, working independently as well as in teams.

Benefits

• Great team
• Well connected site

On behalf of Tenpoint, a successful biotech company in the field of regenerative medicine, we are looking for a dynamic person to complete the team.

Interested? Then we are looking forward to your application.

Please only apply if you fulfil the requirements. Thank you.