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SIRE Life Sciences®

GMP Manufacturing Specialist


SIRE Life Sciences®

GMP Manufacturing Specialist

Location: Leiden, Netherlands
The Company 
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of biologics to protect people worldwide from immunological diseases.

Role Description 
As a GMP Manufacturing Specialist you will be responsible for the introduction of new production processes to manufacturing, as well as manage the possible deviations occurred. 

Responsibilities 
- Execute tech transfers and ensure that new processes are properly introduced to manufacturing. 
- Ensure that bioreactors are ready for production and escalate possible technical issues. 
- GMP documentation; write SOPs and work instructions, change controls, deviations, CAPAs. 
- Create trainings and train operators regarding new processes. 


Requirements 
- MBO, HBO, Bachelor or Master in Biochemistry, Biotechnology or related field. 
- Experience in Downstream and/or Upstream production processes in the biopharmaceutical experience. 
- Experience with GMP documentation is a big plus. 
- Experience with tech transfer and new product introduction a plus.
- Good communication skills in English. 
- Proactive and analytical mindset.  


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 
 
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SIRE Life Sciences®

Job Description

The Company 
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of biologics to protect people worldwide from immunological diseases.

Role Description 
As a GMP Manufacturing Specialist you will be responsible for the introduction of new production processes to manufacturing, as well as manage the possible deviations occurred. 

Responsibilities 
- Execute tech transfers and ensure that new processes are properly introduced to manufacturing. 
- Ensure that bioreactors are ready for production and escalate possible technical issues. 
- GMP documentation; write SOPs and work instructions, change controls, deviations, CAPAs. 
- Create trainings and train operators regarding new processes. 


Requirements 
- MBO, HBO, Bachelor or Master in Biochemistry, Biotechnology or related field. 
- Experience in Downstream and/or Upstream production processes in the biopharmaceutical experience. 
- Experience with GMP documentation is a big plus. 
- Experience with tech transfer and new product introduction a plus.
- Good communication skills in English. 
- Proactive and analytical mindset.  


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 
 

Additional Information

Last updated
Employment type
Full time
Contract type
Permanent
Number of vacancies
1
Min. experience
One year
Min. education
High School
Industry / category
Jobs in Research & Development (R&D), Jobs in Education / Science / Training / EdTech