Senior Scientist Formulation & Product Development - Anderlecht

Vacancy information

Publication date:December 27 2019
Employment type:Permanent
Sector:Pharmaceutical
Function Group:R&D

Functiegroepen: R&D / Product Developer

Organisatie

To continue their ambitious growth, our partner (a Belgian-based pharmaceutical group), is currently looking to hire a Senior Scientist Formulation for a brand new product development lab in Brussels. In this role you will pave the way for all in-house product development activities, which are currently done by contract development organisations. Furthermore you will combine your day to day activities with responsibility as lab representative, thus coming in contact with a wide variety of stakeholders within the company. You will be able to work a to z, from deformation, over formulation and product development, as well as being instrumental in the scale-up towards production. You will thus play an essential role in bringing new generic sterile injectables to the European and US markets, helping patients by giving them cost-effective alternatives.

Functie

You will be fully responsible for the A to Z development and characterisation of sterile dosage forms in solution / suspension / lyophilised powder, based on QbD principles. Furthermore you will act as a lab representative, supervising a team of 4-7 people and report directly to the Senior Management. To be more specific, you can expect to have following responsibilities and activities:

  • Pre-formulation studies, development of early to lead prototypes, manufacturing process optimisation, and identification / qualification of container-closure systems
  • Characterise reference products (formulation composition, grade of excipients and container-closure systems)
  • Coordinate the analytical testing and evaluation of sterile products (release and stability testing based on boundaries identified during Design-of-Experiments (DOE) studies)
  • Generate Quality Target Product Profile (QTTP) based on Quality by Design (QbD) concepts
  • Manufacture sterile dosage forms (0,5L-5L)
  • Identify and establish product performance and device performance studies
  • Draft protocols, reports, standard operating procedures, and work instructions

Functie-eisen

To be successful in this role, you will bring the following expertise related to Sterile Dosage Forms:

  • Master or higher in Analytical Chemistry, Pharmaceuticals, Biopharmaceuticals or equivalent
  • Seven years of industry experience
  • Strong experience in independently formulating, developing, and characterising sterile dosage forms
  • Strong hands-on experience with wet (autoclave) / dry sterilization and aseptic filtration
  • Well-versed in equipment design and operation
  • Strong understanding of chemistry principles and its applications
  • Well-versed with US FDA / EMA requirements
  • Good understanding of QbD-based product development requirements for formulation variables and process variables based
  • Hands-on experience with applications related to Design-of-Experiments


Experience with combination products is considered a plus.

Aanbod

Besides a competitive salary and secondary package, the organisation offers you the chance to be a key player in the set-up and build-up of the product development capabilities in an ambitious company. You will be working in a challenging environment where you are in charge of projects from a to z, for both the European and US market. Furthermore you will have a role with strong visibility within the company, with direct report lines to the Senior Management. You will also be able to increase your managerial skills by leading this lab that will grow to 7 people. As you will grow along with the group, you will have many career developments opportunities within this versatile pharma company with footholds in Belgium, USA, Ireland etc.

Sollicitatie

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Lorin Raats
Consultant R&D | Biotechnological and Pharmaceutical Industry

+31(0)6-30238143
+31(0)23-7548660
l.raats@qtcrecruitment.com

Solliciteren

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