Associate Scientist (Senior Technician) QC-Microbiology-00000NOY
Description
Crucell is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.
For our department we are currently seeking for a fulltime
Associate Scientist (Sr. Technician) QC-Microbiology (m/f)
Department/Project:
The QC-Microbiology team is part of the QC Development Department of the Pharmaceutical and Analytical Development sector. The QCD department is responsible for the release and stability testing as well as the corresponding reporting of Crucell’s virus and antibody products for use in clinical trials and the support of the pilot plant activities.
The QC-Microbiology group is responsible for all microbiological testing and sampling and testing of the water systems located in the pilot plant.
Job Description:
We are looking for a motivated Associate Scientist who enjoys working in a multidisciplinary team.
Your main tasks will be:
Execution of various projects, alone or in a team
Execute and report qualifications/validations
Initiation and implementation of improvements to used assays and techniques
Review and approval of results and documentation
Writing and review of SOP's (Standard Operating Procedures)
Handling of OOS's (Out of Specifications), CAPA's (Corrective and Preventive Actions) and CC's (Change Control)
Writing of trend reports
Participate in planning and coordination of routine and non-routine planned activities
Assist in the performance of various microbiological assays
o Bioburden & LAL on Raw Materials and (intermediate) product
o Environmental Monitoring of the pilot plant
o Growth promotion on media
o Identification of organisms
o Sampling and testing of the water & steam systems of the pilot plant for Bioburden, LAL, TOC, Conductivity and Nitrates
Participation in routine activities is approximately 25%
You are involved in all microbiological related activities. Documentation and Quality (GMP) and efficiency improvements are important factors within QC Development.
Qualifications
Bsc-Microbiology with several years of experience in a similar role or;
A minimum of 5 years on a Technician level, with a proven record of initiating and implementing Change Controls and capable of independent report writing;
Experience within the biopharmaceutical industry and with quality and laboratory systems such as GMP is a must.
Competences:
The candidate fit for the job is accurate, flexible, pro-active and capable to build good relations with all stakeholders.
He/she is capable of keeping the overview and to optimize processes in a dynamic, strong growing environment.
Experience with lab activities in a GMP environment or similar, where documentation plays a major role is considered as a must.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Crucell Holland BV (8852)
Job Function: Quality Control
Description
Crucell is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.
For our department we are currently seeking for a fulltime
Associate Scientist (Sr. Technician) QC-Microbiology (m/f)
Department/Project:
The QC-Microbiology team is part of the QC Development Department of the Pharmaceutical and Analytical Development sector. The QCD department is responsible for the release and stability testing as well as the corresponding reporting of Crucell’s virus and antibody products for use in clinical trials and the support of the pilot plant activities.
The QC-Microbiology group is responsible for all microbiological testing and sampling and testing of the water systems located in the pilot plant.
Job Description:
We are looking for a motivated Associate Scientist who enjoys working in a multidisciplinary team.
Your main tasks will be:
Execution of various projects, alone or in a team
Execute and report qualifications/validations
Initiation and implementation of improvements to used assays and techniques
Review and approval of results and documentation
Writing and review of SOP's (Standard Operating Procedures)
Handling of OOS's (Out of Specifications), CAPA's (Corrective and Preventive Actions) and CC's (Change Control)
Writing of trend reports
Participate in planning and coordination of routine and non-routine planned activities
Assist in the performance of various microbiological assays
o Bioburden & LAL on Raw Materials and (intermediate) product
o Environmental Monitoring of the pilot plant
o Growth promotion on media
o Identification of organisms
o Sampling and testing of the water & steam systems of the pilot plant for Bioburden, LAL, TOC, Conductivity and Nitrates
Participation in routine activities is approximately 25%
You are involved in all microbiological related activities. Documentation and Quality (GMP) and efficiency improvements are important factors within QC Development.
Qualifications
Bsc-Microbiology with several years of experience in a similar role or;
A minimum of 5 years on a Technician level, with a proven record of initiating and implementing Change Controls and capable of independent report writing;
Experience within the biopharmaceutical industry and with quality and laboratory systems such as GMP is a must.
Competences:
The candidate fit for the job is accurate, flexible, pro-active and capable to build good relations with all stakeholders.
He/she is capable of keeping the overview and to optimize processes in a dynamic, strong growing environment.
Experience with lab activities in a GMP environment or similar, where documentation plays a major role is considered as a must.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Crucell Holland BV (8852)
Job Function: Quality Control