Vacancy for a Senior QC Technician
Full time position
You will be responsible for the analytical development and validation of our assays used for in-process control, product release and characterisation for our cell and gene therapy products. The work typically includes method transfer, verification, qualification and validation. Our products are at the forefront of cell and gene therapy development using our NK-cell platform. Therefore, the function requires a strong scientific understanding of a candidate being able to translate and optimise non-standardised methods that will need to be applied within our QC-testing activities. Emphasis is on a series of methods for characterisation of cell therapy products. In this context a candidate ideally should have experience with potency assays, viability, product and process related impurities, stability studies and viral transduction. You will have a leading role within our QC-team.
The Analytical Development Scientist works effectively with the production, development, QA, QC and RA-department and reports to our Chief Regulatory and Quality Officer.
- Coordinating analytical development;
- Coordinating the activities of the QC-team;
- Method development;
- Qualification and validation of analytical assays;
- Creating assay development Strategy;
- Creating and maintaining analytical procedures, protocols and reports;
- QC testing;
- Initiating and managing reference standards, deviations and change controls;
- Qualification and maintenance of analytical equipment;
- Contact with contract laboratories regarding testing of samples; and
- Set-up and coordinate stability studies.
Education, skills and experience
The job as Analytical Development Scientist will be held by a person with:
- Relevant technical education HBO+, MSc or PhD in a relevant field;
- 5-10 years of experience within GMP environment in bio(pharma) manufacturing environment;
- Experience in relevant methods including flow cytometry;
- Experience within analytical testing of cell or gene therapy products;
- Independency and ability to manage and work in small teams.
- Excellent communication and writing skills, Working knowledge on relevant EMA/FDA guidelines; and
- Hands on mentality
Conditions of employment:
- After a successful trial period a permanent contract is extended;
- Competitive salary, after your first year your salary will be adjusted accordingly with your performance and dedication;
- Pension premium contribution;
- Travel allowance or public transport reimbursement;
- 25 holidays; and
- Holiday pay.
Do you have what it takes?
Please convince us by sending your motivation and CV in English to Liana van Genuchten (HR@Glycostem.com).
We reply to you within 3 working days.
Want to know more?
E-mail our HR department at HR@Glycostem.com for more information about Glycostem and the selection process.
Recruiters should not contact us.
Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.