Process Developer

Mechelen, Belgium / 2016046
Contact

Biocartis NV / Email: HR@biocartis.com

Function Type
Full time
Experience Required
  • Experience with with qualification and validation activities in a GMP environment is a strong asset;
  • Experience in IVD process development is an added value;
  • Experience in technical transfer of biotechnology processes is a strong added value;
  • Experience with change control processes is an asset.
Education
  • A degree in engineering with preferably 3 years’ experience in chemistry, biochemistry or molecular biology in a medical, pharmaceutical or diagnostic industrial environment;
Functional Area
Manufacturing
Travel Percentage
5

 

Position within the organization

The Process Developer will work in the functional Area of New Product Introduction into Manufacturing.  The Process Developer is a member of the Make sphere.

 

Purpose of the position

The combined focus of the Process Developer will be to support and drive changes to on market products (Life Cycle Management), as well as to develop the production process of new products.

 

Tasks/outcome domains

  • Take responsibility for the maintenance and update of the design transfer and device master record processes and act as the first point of contact (The position is owner of the Design transfer and Device Master Record processes).
  • Take responsibility in the coordination and execution of design change related projects with regard to on market products.
  • Take responsibility for main events related to process development, verification, and validation of assay specific individual process steps.
  • Collaborate, support, and communicate efficiently with relevant team members, such as Assay Development, Stability and QC Method Development, Supply Chain, Operations and QA to ensure methods and technology are consistent throughout the company.
  • Perform an efficient design transfer to Supply Chain and Operations in a standardized fashion.
  • Present own work at in-house forums and at outside professional meetings.
  • Write protocols, reports, technical reviews, transfer documentation and SOPs autonomously.
  • Give support to or take the lead in preparing assay process related documentation and specifications.
  • Plan, carry out, and supervise process trials.

 

Profile and competencies

  • A degree in engineering with preferably 3 years’ experience in chemistry, biochemistry or molecular biology in a medical, pharmaceutical or diagnostic industrial environment;
  • Experience with with qualification and validation activities in a GMP environment is a strong asset;
  • Experience in IVD process development is an added value;
  • Experience in technical transfer of biotechnology processes is a strong added value;
  • Experience with change control processes is an asset;
  • Technical leader who can function independently;
  • Basic knowledge of sample preparation, NA extraction and real-time PCR;
  • Excellent technical writing skills (protocols, reports, standard operating procedures, test methods) and good documentation practices are a must;
  • Ability to interpret data;
  • 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;
  • Strong teamplayer with a personal drive;
  • Stress-resistant;
  • Well developed interpersonal skills;
  • Hands on and pragmatic approach;
  • Flexible;
  • Advanced knowledge, orally and  writing in Dutch and English;

 

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 motivational letter in English)  to HR@biocartis.com using the job ID 2016046 as a reference. 

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