General information

Sr Biochemistry Analyst
For strengthening our QC department HAL Allergy is currently looking for a Senior Biochemistry Analyst.
As a Senior Biochemistry Analyst you will be responsible for maintaining the progress and execution of a variety of analytical tests that are required for the release of raw materials, intermediate products and/or end products. Your contribution will be critical, because all tested materials will be used for the manufacturing of Hal Allergy’s immune therapeutics.
Tasks and Responsibilities

You will be involved in the coordination of various activities at the QC lab (e.g. the coordination and completion of various improvement processes), and you will replace the Supervisor Biochemistry in case of his/her absence. 

  • Responsible for the progress, correct execution and reporting on all QC related analyses;
  • Responsible for the coordination of various improvement processes yielding a QC/Biochemistry department that is operating more efficiently;
  • Responsible for maintaining an overview on trend files so you will be able to early signal in case of trend deviations;
  • Execution of a high variety of routine based biochemical assays by following Standard Operational Procedures (SOPs) yielding (final) product releases and the generation of data for stability studies;
  • Independently assess analytical assay results and directly report to the Supervisor Biochemistry on occurring deviations;
  • Involved in the execution of trouble shooting, method optimization and validation of (new) analytical methods within the QC department, acting as the first point of contact for Analytical Development;
  • Responsible for the generation of accurate and complete project reports as well as the processing of analytical data in LIMS;
  • Responsible for generating and/or improving QC documentation using the Pharmaceutical Documentation System;
  • Involved in the training of new QC colleagues;
  • All activities are executed under strict GMP regulations.
Requirements
  • At least HBO Bachelor within Biochemistry or related field;
  • At least 8 years of experience within a pharmaceutical development and/or production environment;
  • Extensive and proven experience in the execution and/or validation of ELISA assays;
  • Experience with working under GMP-related quality systems, including Deviations, root cause analysis tools, CAPA’s, and Change Control;
  • Experience in participating in technology transfers;
  • Experience in working with HPLC/UPLC, SDS-PAGE, spectrophotometry, and immunoblot, is considered as an advantage;
Personal & Professional Skills

You as a person are result oriented, accurate, pro-active and you have strong interpersonal – and communication skills.

  • Experience in problem solving, critical thinking while using a hands-on mentality, willing to take responsibility and supportive/coaching approach;
  • Ability to guide and motivate people, with a strong focus on collaboration, transparency, and team effectiveness;
    Ability to coordinate QC activities and act as a deputy supervisor (in case the Supervisor Biochemistry is absent);
  • Ability to provide effectively written reports;
  • Fluency in both English and Dutch is a prerequisite.
Offer
  • We offer you a highly dynamic job in an interesting environment.
  • You will be working from our headquarters in Leiden, where the products are produced on site.
  • HAL Allergy offers great benefits including a competitive salary, 13th month, 30 holidays, contribution to pension and health insurance.
Applications and more information
Interested? We look forward to receiving your application. To apply, please click the "Apply" button below to the right where you will be prompted to upload your CV first. 
Company Information

HAL Allergy is a modern leader in the field of biopharmaceuticals, located in the Leiden Bio Science Park in The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases.

 

With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has a long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect, resulting in a reduction of symptoms and long-term disease suppression. These therapies are primarily used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings.

 

We employ around 300 highly specialized people across various functions. The departments at our headquarters include Research & Development, Production, Quality Assurance, Clinical Development and Regulatory Affairs. Our staff works closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.

 

We are a steadily growing and dynamic company with a culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.

 

In addition to the core business of HAL Allergy, our subsidiary HALIX was founded in 2012. HALIX is a contract development and manufacturing organization (CDMO) licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. As an end‑to‑end service provider, HALIX will serve its customers the full range from the first development steps to start of commercial production after successful registration of products.