An innovative biopharmaceutical organisation that focuses on development of therapeutic proteins.
Wat ga je doen - What will your job be
Are you a communicative hbo or MSc candidate and do you have several years of industrial experience in a QC production environment? As a QC Scientist you play a key role in the development and evaluation of analytical methods used for QC testing of starting materials, Drug Substance (DS) and Drug Products (DP). Interested? Keep reading!
As a QC Scientist you are responsible for the management of current and new analytical test methods to support release of product for commercial and/or clinical purposes. This does not include any laboratory work, since all QC testing of starting materials, DS and DP is outsourced at CLOs/CMOs. Instead you will act as a contact person for contract partners giving advice and contribute in the development of analytical methods. Furthermore, you will become the QC representative in multiple projects. Your key responsibilities:
- Be the contact person for QC testing of starting materials, DS and DP outsourced at CLOs/CMOs
- Troubleshooting, monitoring/qualification of critical materials and reference standards
- Life Cycle Management, validation and transfer of existing and newly developed analytical methods
- Advice and contribute in developing/evaluating analytical methods, specifications and stability studies
- Coordinate all QC tasks within the projects
Wat vragen wij - What are we looking for
For the position of QC Scientist we are looking for an hbo or MSc candidates with several years of industrial experience working in a QC routine production environment, preferably within the pharmaceutical industry.
- You have a hbo or MSc in Life Science or similar
- Good knowledge of GMP requirements for analytical methods and hands on experience with guidelines (FDA, EMA and ICH)
- Experienced in setting up validations and or transfers of analytical methods
- Experience with evaluation and setting up SST and acceptance criteria
- As a person you are communicative and flexible having excellent coordinating skills
- You have fluent Dutch and English language skills
Wat hebben we te bieden - What do we offer
- Long-term employement starting directly with a contract at the company
- Fulltime position (40 hours/week), 32 hours/week is discussable
Wil je meer weten - More information
Neem voor meer informatie contact op met Jurjen Wilschut: 088 00 21 122 // 06 302 47 453