PlusOne

Head of Quality Control Laboratory

About PlusOne

PlusOne - HIRING TALENTS for STARTUPS & SMEs - SCIENCE&TECHNOLOGY :

Bringing the right people on board is important for any business, but small companies in particular can’t afford to make hiring mistakes! PlusOne is the recruitment partner of small innovative companies and can help you to attract and retain top talents! We specialized in scientific and engineering talents (PhD and master). We have a very good track record in the following areas: pharmaceutical, biotechnology, cell therapy, materials, medical devices, aerospace, robotics, electronics, numerical simulation ... Targeted profiles: CXO, Managers, Experts Clients: SME, spin-off, start-up, Research Centers, Incubators... PlusOne is the first recruitment office entirely dedicated to SMEs active in the field of science or technology in Belgium. Is your SME, start-up or spin-off looking for new staff and doesn’t have enough time or competent resources necessary to handle recruitment? Do you fear the costs associated with the services of a recruitment firm and that you might not find the right contact to deliver results? Meet us on Facebook and like our PlusOne Recruitment page!

Company

Our client is a clinical stage biotechnology company developing a pipeline of vaccines and immunotherapies based on its proprietary technology. One of its mission is to revolutionize influenza prevention with a universal flu vaccine currently in phase 2a covering both current and future influenza infections. To reinforce their team, they are looking for a Head of Quality Control Laboratory for a permanent position in Liège.

Role

  • Provides support to the transfer of the analytical methods from the R&D/Analytical Development group to the QC Laboratory
  • Manages the stage-appropriate qualification and validation of the analytical methods in support of the product development activities and associated regulatory submissions, including the writing of the protocols, the execution of the tests, the assessment of the results and the writing of the reports and suitable regulatory source documents, in compliance with the relevant regulatory guidelines
  • Ensures that all relevant analytical activities are performed in accordance with GMP (as required), company SOPs and Health and Safety policies
  • Prepares, approves, monitors and reviews specifications for finished drug substances and products in close collaboration with the R&D and Regulatory Departments
  • Ensures testing and release of drug substances and drug products according to the corresponding, most current specifications as defined in the regulatory submissions (IMPD, IND)
  • Acts as the main point of contact on all GMP quality control matters, internally and externally
  • Ensures the maintenance of QC equipment – qualification, calibration and maintenance
  • Participates to CMC Project Team meetings as applicable
  • Assists regulatory audits and responds to audit observations and corrective actions
  • Provides relevant technical assistance and training for personnel
  • Files and maintains relevant controlled documents
  • Maintains/expands the scientific and technical standards applicable to the Company analytical technology portfolio through the monitoring of all applicable regulatory guidelines related to drug substance and drug products release and stability studies throughout the development lifecycle

Profile

  • Master or Doctorate Degree in Life Sciences, Bio Engineer or Industrial Pharmacist
  • Experience in pharma, audit, GMP, is an asset
  • Experience with managing people and providing leadership
  • Thorough knowledge of GMP regulations related to Quality Control required
  • Experience in analytical method development and validation of large recombinant proteins
  • Experience in the recombinant protein biochemistry and immunology analytical techniques, including ELISA, electrophoresis and chromatographic (HPLC) techniques
  • Presentation & training skills
  • Fluent in French & English

Offer

Permanent contract

Workplace: Liege

Publication date

18.11.2020

Contact person

DORTU

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