Jr. Research Associate Analytical Chemistry

Région
Tienen
Publication
vendredi 10 mars 2017
Date limite
lundi 10 avril 2017
Réf
703D2XPE-BE
Contact
Sandra Rizzuto
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Jr. Research Associate Analytical Chemistry Organisation description:

This temporary 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 management activities. A company active in medical devices and pharmaceuticals.

Job description:

Essential duties & responsibilities:

  • Actively support the life cycle management activities, including product/process change control, risk management activities.
  • Work with manufacturing partners to transfer activities and solve problems.
  • Design appropriate experiments to solve technical problems and to lower proactively project – risks.
  • Organize 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.
  • Develop, validate and perform chemical analysis methods on a variety of samples. Perform critical review of data obtained and issue reports
  • Participate in multi functional project teams for the development of new products. Planning of development activities. Develop effective project milestones and schedules.
  • Set up and perform studies to test ideas for new pharmaceutical and device solution till the registration studies to support New Drug Application.
  • Collaborate with Universities, Partners or hospital to generate new ideas or support the development of new solutions.
  • Ensure IP protection or freedom to operate.
  • Review the literature and all guidelines on frequent base.
  • Maintain 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 activities.
  • Actively participate and support required QMS activities, including complaint and pharmacovigilance reporting.
  • Profile:

    Qualification: Master in Sciences, Industrial Engineering degree or Ph.D. in Life Sciences without industrial experience Skills:

  • Ph.D. in Life Sciences (physiology, biochemistry, biology, chemistry) is an asset
  • Thorough knowledge of physiology and analytical chemistry.
  • Proven ability to work independently.
  • Experience designing and implementing technical studies.
  • Demonstrated technical writing proficiency/authoring internal reports and scientific papers.
  • Experience conducting database research for the acquisition of desired information.
  • Ability/experience interpreting results from complex instrumentation and scientific studies.
  • Ability to establish clear lines of communication to key stakeholders for favorable outcome of projects.
  • Good knowledge of the requirements of pharmaceutical and medical device development (ICH guidelines, EN ISO13485, MDD 93/42/EEC, GMP) is an asset.
  • Excellent oral and written communication skills.
  • Fluency in English.
  • Intermediate to advanced computer skills. Able to travel (10%)
  • Offer:

    Contract of 12 months with interesting advantages. Possibility to receive a fix contract after the period of 12 months.



    Licenses
    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