@Biocartis_

QC Development & Stability Expert

Mechelen / 2016021
Contact

Biocartis NV / Email: HR@biocartis.com

Function Type
Fulltime
Experience Required

min. 5 years of experience in chemistry, biochemistry or molecular biology in  industry is a must, preferably in a medical or diagnostic environment

affinity with QC method development and/or stability

basic knowledge of DNA/RNA extraction and real-time PCR

Education

Master degree;

Ph.D. is a nice to have

Functional Area
R&D
Travel Percentage
5

Position within the organization

The function ris part of the CREATE sphere and is part of the menu development team.

 

Purpose of the position

The QC Development Expert is 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).

 

Tasks/outcome domains

  • 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 

 

Profile & competencies

  • 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
  • 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
  • Good time management skills
  • Problem identification, analysis and solving skills
  • Scientific integrity
  • Results-oriented and an eye for detail
  • Strong analytical skills
  • Flexible and eager to learn novel concepts

 

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.

 

Interested?

Please apply by e-mail  (Resume and motivation letter in English)  to HR@biocartis.com using the job ID 2016021 as a reference. 

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