Method development and validation specialist

Onze klant te Mechelen is gespecialiseerd in diagnostics en medical device.

Momenteel zijn we op zoek naar een Method development and validation specialist voor een vaste functie.

 You are responsible for the development, qualification and validation of (analytical) release and stability methods for new developed IVD products and makes recommendations for the performance of experiments in the area of quality control (QC).

 

  • Plans and performs experiments with a high degree of independence, performs trending and interprets data in order to draw conclusions. The QC Development Expert also writes protocols, reports, and transfers documentation on (analytical) test methods and QC methodologies.
  • Supports, plans and monitors progress of the assigned development projects in line with business priorities;
  • Oversees overall QC development resource demand vs capacity;
  • Final technical  responsibility on QC Method Development & Stability during all phases of the Assay Development Projects;
  • Has a profound understanding of method development, qualification and validation of (analytical) QC methods including instrument qualification and validation
  • Assist in setting up and maintaining stability processes for raw materials as well as QC test panels
  • Applies state-of-the-art knowledge to assigned project(s), has a high level of technical proficiency, and modifies and introduces new methodologies to improve the quality, accuracy and usefulness of data
  • Interface with R&D and Operations organizations to ensure methods and technology are consistent throughout the company
  • Lead troubleshooting activities for established test methods used in development and release testing
  • Provide  support in formulation optimization and process development
  • Keeps abreast of current developments and literature relative to new QC methodologies and performs literature searches on own initiative.
  • Presents own work at in-house forums and at professional meetings
  • Is able to write protocols, reports, technical reviews, transfer documentation and SOPs autonomously
  • Follows policies, SOP’s and other applicable guidelines 

Profiel:

  • Master degree with min. 5 years of experience in chemistry, biochemistry or molecular biology in  industry is required, preferably in a medical or diagnostic environment is required
  • PhD is a nice to have
  • Strong knowledge of QC method development and/or stability
  • Basic knowledge of clinical sample preparation, DNA/RNA extraction and real-time PCR
  • Ability to write protocols, reports, standard operating procedures and test methods
  • Experience with analytical techniques is a strong asset
  • Ability to interpret data and have strong analytical and problem-solving skills
  • Knowledge of statistical techniques, such as data trend analysis and design of experiments and relevant software tools, is highly desirable
  • Strong attention to detail and quality driven
  • Excellent oral and written communication skills
  • Ability to manage multiple priorities
  • Ability to execute effective decision-making, both as an individual and as part of a team and planning
  • Perfect English written and spoken
  • You have knowledge of relevant software tools (e.g. data analysis)
  • You are technology-orientated
  • Teamplayer and able to work independently

 

Contact:

Els De Meester

elsd@labsupport.be

03 808 21 79