Helaas is deze vacature inmiddels waarschijnlijk verlopen
Quality associate and Biotech associate
- Quality associate and Biotech associate
- Alleen beschikbaar in het Engels*
CiMaas focuses on further product development of its’ dendritic cell vaccine as well as NK cell expansion protocols. CiMaas will perform clinical trials and both products will be produced in our GMP facility.
The challenge
You will have the opportunity to be part of a young, dynamic and developing organization that is involved in combating cancer. As a member of a small and enthusiastic team of professionals, you make an important contribution to the challenging development of specific cell therapeutic agents in a GMP environment. You have sufficient experience and seniority to support the team content wise.As a Quality Associate or Biotech Associate, you report to the Quality Manager and/or the Scientific director (CSO).
You work on the production of the DC vaccine and the NK cells, the preparation of SOPs and the creation and validation of QA and QC protocols in accordance with GMP guidelines.
The ideal candidate
- Bachelor’s degree in biochemistry/biotechnoloy (eg HLO)
- At least some years hands on experience in cell culture, eg knowledge of bioreactors or scaling up of experiments and cell analysis including FACS phenotyping and cytokine production
- Several years of experience in a GMP environment
- Good communication skills in English in word and writing
- If you apply for Quality Associate, experience in this position is require
vacature at cimaas.com
Task and result
Quality Associate position
- Responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements and existing GMP standards and assist activities of the CiMaas Quality System .
- Responsible to stay abreast of the professional standards of the QA position and has to actively contact supervisory staff in case a need for training/qualification appears.
- Judgement of batch related documents and plan and execute QA activities including documentation, including write, review, approve, handle, distribute and archive documents.
- Monitor compliance with all applicable GMP and safety standards and support Quality Manager and QP in their roles, including audits and QA training.
Biotech Associate position
- Carrying out all tissue culture activities for cell therapy, from starting material to final product, according to relevant procedures both at R&D level as well as under GMP conditions.
- Carrying out associated duties e.g. required cleaning of production areas, assisting
- in (re)qualification of equipment, and logistic activities.
- Reporting and reviewing of all required process steps in approved batch records.
- Notification of supervisor (COO/CSO) of all observed deviations in a timely manner.
- Initiation and follow up of deviations, CAPA's and Changes.
The competencies
- Taking initiative and responsibility
- Self-organized and organization skills
- A problem-solving attitude and a hands-on mentality
- Being able to work independently and in a team
- Good social skills
- Quality-oriented, tideness and accurate
- Flexible
- Targeted and driven
- Prepared to work in weekends / off-hours
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