You are here
Manager Pharmaceutical Development
About Our Client
Our client is a bio-pharmaceutical company that develops innovative, state-of-the-art products. They focus on research, development and further commercialisation of their products, that provide a safer and more efficacious treatment for blood disorders. Furthermore, they are continuously improving the survival and quality of life for patients, and addressing significant unmet medical needs.
As a Manager Pharmaceutical Development, you have a thorough understanding of the complexity of manufacturing, extensive knowledge of the relevant guidelines, and you have experience in (bio)pharmaceutical validation. Your main responsibilities will include Quality Control, validations and stability studies within the organisation. Furthermore, you will lead the QC and essay development team (4 FTE) and report directly to the Vice President CMC.
For this dynamic position, we are looking for an enthusiastic, all-round person with a strong background in (bio)pharma and experience in a manufacturing environment.
Responsibilities include, but are not limited to:
- Process Development and Validation;
- Analytical Validation;
- Validation of other manufacturing related activities;
- Qualification of raw materials;
- Writing and supporting CMC-sections of regulatory documents;
- Translating the guidelines into executable protocols.
The Successful Applicant
- Minimum of a Master degree in the (bio)Pharmaceutical industry;
- 5 years of experience in (bio)pharma/bio-tech;
- Experience with cell based medicinal products or ATMPs;
- A thorough understanding of the complexity of manufacturing;
- Knowledge of the relevant guidelines (ISO, GMP etc);
- Experience in pharmaceutical validation;
- An appreciation of complexity of personalised cell based medicine;
- Excellent communication skills and a fluency in English (verbal and written).
What's on Offer
- One year contract with the intention for extension to an indefinite contract;
- Very competitive salary and bonus;
- Attractive secondary benefits;
- Full-time or part-time working hours;
- Travelling abroad once in a while.