eXPErt services for eXPErt professionals.
For one of our clients we are looking for:
Jr. Research Associate Analytical Chemistry
position (12-months with possibility to receive a fix contract) will be responsible for the life-cycle management of pharmaceutical solutions
and medical device products for our client. The key responsibility of the
Research Associate is to provide technical expertise in the areas of CMC
development, formulation development, analytical methods development and
validation, and manufacturing process development, validation and transfer. The
Research Associate will manage product/process change controls as well as risk
A company active in medical devices and pharmaceuticals.
duties & responsibilities:
support the life cycle management activities, including product/process change
control, risk management activities.
manufacturing partners to transfer activities and solve problems.
appropriate experiments to solve technical problems and to lower proactively
project – risks.
and provide technical leadership in the areas of CMC development and review,
formulation development, analytical methods development and validation,
preclinical activities, and manufacturing process validations. Set up studies
to generate the necessary results.
Review the experimental data and validate the results. Report and present the results.
validate and perform chemical analysis methods on a variety of samples. Perform critical review of data obtained and
in multi functional project teams for the development of new products. Planning of development activities. Develop effective project milestones and
Set up and
perform studies to test ideas for new pharmaceutical and device solution till
the registration studies to support New Drug Application.
with Universities, Partners or hospital to generate new ideas or support the
development of new solutions.
protection or freedom to operate.
literature and all guidelines on frequent base.
current knowledge of relevant Quality System Regulations and other regulatory
requirements related to research and development (product development, design
and safety) to ensure compliance in all research, data collection and reporting
participate and support required QMS activities, including complaint and
Master in Sciences, Industrial Engineering degree or
Ph.D. in Life Sciences without industrial experience
Life Sciences (physiology, biochemistry, biology, chemistry) is an asset
knowledge of physiology and analytical chemistry.
ability to work independently.
designing and implementing technical studies.
technical writing proficiency/authoring internal reports and scientific papers.
conducting database research for the acquisition of desired information.
interpreting results from complex instrumentation and scientific studies.
establish clear lines of communication to key stakeholders for favorable
outcome of projects.
knowledge of the requirements of pharmaceutical and medical device development
(ICH guidelines, EN ISO13485, MDD 93/42/EEC, GMP) is an asset.
oral and written communication skills.
to advanced computer skills.
Able to travel (10%)
Contract of 12 months with interesting advantages. Possibility to receive a fix contract after the period of 12 months.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713