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CMO Project Manager
Het bedrijf / The company
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.
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.
The CMO Project Manager is responsible for planning and managing the introduction of new products and/or technologies at HAL Allergy. As the key contact person for the customer, you act as liaison between the customer and the operational organization, such as Production, QA/QC and Supply Chain.
De functie / The role
Tasks and responsibilities
- Lead projects (of internal processes and CMO projects) in order to make changes in production processes possible. Strongly interact with different stakeholders involved in the project: external customer, QA, QC, manufacturing, etc.
- Responsible for technical transfer of existing and new process technologies in production processes.
- Provides insight and guidance to current processes and new production technologies. Improve and extend existing techniques in our production processes, including consequences for the production chain.
- Ensure the transferred production processes meet GMP regulations.
- If needed, prepare validation protocols for manufacturing processes. Surveillance and execution of validation tests.
- Lead with aspects related with the projects as risk analysis, CAPA, change control, process investigations, continuous improvement etc.
Het profiel / Your profile
- Minimum Bachelor"s Degree.
- A minimum of 5 years of experience in the pharmaceutical industry in a relevant position.
- Experience in managing projects, preferably projects with international customers.
- Good understanding of GMP regulations.
- Good knowledge of pharmaceutical processes like filtration, formulation and freeze-drying.
Personal & Professional Skills
- Result oriented. Able to offer pragmatic solutions.
- Ability to think and act strategically.
- Ability to stimulate teams and individuals.
- Open mindset, flexible, able to adapt to different situations.
- Good communication skills.
- Proficient in both Dutch and English, both verbal and written.
Het aanbod / The 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.
Reactie / Reaction
Are you interestedin this posotion at HAL Allergy? Please send your CV and motivation letter to us via this apply link: https://hal-allergy-cand.talent-soft.com/Pages/Offre/detailoffre.aspx?idOffre=1110&idOrigine=3181&LCID=2057&offerReference=2018-1110
Tenslotte ..... / Finally ....
We are looking forward to be hearing from you. In case you have questions regarding this vacancy, please contact S. Mens via 088-1959000.