Quality Control Department Manager – biology-biochemistry


Availability: Dès que possible
Job description:

Yposkesi is one of the largest Contract Development & Manufacturing Organizations (CDMO) in Europe for gene therapy viral vector manufacturing. A spin-off from the world-class gene therapy pioneer Genethon, Yposkesi capitalizes on more than 20 years’ expertise in biotherapeutic research.

  • Integrated Services

It offer customers a full service: bioprocess development (upstream and downstream processing), small/pilot to large-scale production, analytical development, GMP manufacturing of clinical lots of lentiviral and AAV (Adeno-Associated Virus) vectors and regulatory support.

  • Capacity

Its current 50,000ft2 state-of-the-art facility designed for high efficiency houses four independent manufacturing suites for bulk drug substance and two fill & finish suites. It is doubling this footprint to 100,000ft2 to expand its capacity to support the clinical and future commercial needs of its clients.

  • Innovation

Yposkesi invests significantly in bioprocessing innovation aimed at improving the cost-effectiveness of gene therapy manufacturing.

Founded in 2016 by patient association AFM-Telethon and the SPI investment fund from BpiFrance, the state-owned French investment bank, Yposkesi is driving its ambitions through the leadership of directors with an established track record in gene therapy and pharmaceutical GMP-biomanufacturing. The company is located in Corbeil-Essonnes, near Paris, and employs 160 industrial and technical specialists.

Detailed mission:

Your main mission is to manage the department in charge of cell and molecular biology analysis (cell culture and transfection, PCR, ELISA, Electrophoresis and Western Blot) and biochemical analysis in compliance with GMP/cGMPs, Pharmacopoeias and health and safety rules.

In this respect you will:

  • Manage a team of 7 employees including an assistant: you manage recruitment, skills development, training and individual assessments.
  • Be accountable for the organisation of analytical work: you organise and plan internal and outsourced analysis for routine and stability analysis.
  • Guarantee analytical deadlines, implement the necessary actions to meet those deadlines and inform the relevant people.
  • Control product results and their compliance with specifications.
  • Take part in choosing any new equipment, analytical subcontractor and reagent supplier and in optimising operating costs.
  • Create and update the department’s control documents and ensure they are in line with technical and regulatory guidelines.
  • Take part in the transfer of methods and analytical validations in collaboration with the relevant departments.
  • Guarantee the compliance of practices with the regulatory references (PE, USP, ICH…) and can provide documented proof if required.
  • Manage quality events attached to your department: you initiate and manage laboratory investigations, analyse and conclude the investigation in compliance with the deadlines and current investigation procedures.
  • Manage your team’s performance regarding quality and productivity. You carry out the department’s activity reports required for its monitoring and working out Quality Control parameters.
  • Take part in external audits of suppliers or analytical subcontractors.

You hold a Master level degree in Biology/Biochemistry applied to health products or equivalent. You have a minimum of 3 years of experience on a similar position (technical expertise, management and quality control) within a GMP/cGMP environment.

You are familiar with cell and molecular biology techniques.

Analytical experience of viral vectors is an asset.

You have a sense of service and organisation to meet customer expectations and will be able to lead any necessary changes.

You are open-minded, receptive and teamwork-oriented which will allow you to contribute to the department’s animation following a constructive and team-development-oriented dynamic by ensuring regular and honest reporting.

Thorough, pragmatic and a people person, you are also proactive.

You have a good English knowledge and will be able to communicate with external clients.