Geplaatst op

30+ dagen geleden

Beschrijving

General information
Project Lead Technology Transfer
The Project Lead Technology Transfer (TT) is responsible for the introduction of new processes or materials into the operational departments, such as Production and Quality Control. He/she leads teams of operational experts from Production, QA/QC and Regulatory Affairs, and represents Operations in R&D project teams. In addition, the Project Lead TT may provide technical and organisational support to post-marketing changes as part of the HAL product portfolio.
Tasks and Responsibilities
  • You participate in multidisciplinary project teams and contribute to the project goal by delivering and executing operational activities and milestones.
  • You ensure high-quality of the work performed by the team and make sure that new and improved manufacturing processes/analytical methods comply with relevant regulatory guidelines (e.g., GMP).
  • You plan and prioritise own work, and co-ordinate that of project team members, in line with targets and to ensure that deadlines are met.
  • Work with and manage contacts with external organizations, analytical laboratories and technical consultants.
  • You play an advisory role/provide technical support within the Technology Transfer department.
  • Translate requests of client into a clear project scope/plan.
Requirements
  • Minimum BSc degree in Life Sciences with a minimum of five years of relevant experience in pharmaceutical (CMC) product development or industry.
  • Solid experience in project management in the field of (bio-)pharmaceutical product development in an industrial setting.
  • Good knowledge of pharmaceutical processes like filtration, formulation, filling and freeze-drying.
  • Experience with technology transfer from Development and/or clients to GMP production.
  • Experience with regulatory submissions and/or variations, such as IMPD or Type II.
  • Good knowledge of GMP and relevant pharmaceutical regulatory guidelines.
  • Good knowledge of and experience with validation and transfer of manufacturing and analytical processes.
Personal & Professional Skills

You are a result oriented professional with the ability to work on different types of (CMC) projects. You can communicate and cooperate well with different stakeholders of various levels in and outside the organisation. With different projects and deadlines ongoing, you are able to plan your work and that of the project teams well.

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.

Source: HAL Allergy