QC Scientist

Company: CheckMark Labrecruitment
Job type: Full-time

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 Waar ga je aan de slag - Where will you work An innovative biopharmaceutical organisation that focuses on development of therapeutic proteins. Locatie Regio Leiden 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: // Vacaturenummer: 6714

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