• Full Time
  • Kigali

Website BIONTECH

Who we are:
As BioNTech, We are a global immunotherapy company. Our 3,000+ colleagues globally are committed to improving the health of people worldwide with our fundamental research utilizing the full potential of the immune system to fight cancer, infectious diseases, and other serious diseases. We leveraged our mRNA technology to develop a COVID-19 vaccine which became the first mRNA drug approved for human use.

What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”.  The aim is to build a regional manufacturing network in Africa, with Africa, for Africa.

Why we need you:
The BioNTainers will be equipped to produce a range of mRNA-based vaccines targeted toward the needs of African Union member states. You will become part of the regional staffing team, driving the establishment of the regional African end-to-end mRNA manufacturing network.

Role purpose

Directly supports production in one or several production steps for all process specific issues in order to ensure on-time completion of processes, continuous quality and productivity improvements, and compliance with cGMP regulations, SOPs, guidelines, and functional standards (e.g. SHE).

Tasks

  • Close collaboration with global process lead to ensure local process application
  • Prepares and maintains master production documentation for the assigned products, including masterbatch records (MBRs), material parts lists, recipes, risk assessments (QRAs), Zurich risk analysis, and ensures that production SOPs are updated and/or prepared.
  • Ensures that global process is copied by 100% to ensure regulatory approvals
  • Directly supports production by collaborating with shift teams to ensure that all batches are produced safely, on time, and in compliance with manufacturing specifications and quality requirements.
  • Prepares and maintains master production documentation for the assigned products, including masterbatch records (MBRs), material parts lists, recipes, risk assessments (QRAs), Zurich risk analysis, and ensures that production SOPs are updated and/or prepared.
  • Ensures that all critical parameters are within written regulations (e.g. masterbatch record, risk assessment, validation batch record)
  • Acts as subject matter expert (SME) for product and process knowledge, has extensive subject matter expertise for product and process trends by supporting the APQR process when analyzing and promoting technological process innovations and when implementing process control strategies.
  • Processes complex, cross functional non-conformances as head of the investigation, and implements CAPAs
  • Ensures that processes are ready for inspection
  • Supports process optimizations and new technology rollouts to ensure continuous productivity improvements, performs scale-ups
  • Assists with process transfers.

Qualifications

Education:

Completed academic degree (Master/Diploma) in engineering, pharmaceutical technology, chemistry, pharmaceuticals, or equivalent academic natural sciences degree

Professional experience:

  • At least 3-5 years of sector-specific experience

Languages:

  • English fluent spoken and written

Competencies:

  • Pronounced team & communication skills
  • Constructive work habits, flexibility, solution orientation, job ownership, quality appreciation
  • Self-starter and learning capacity
  • Willingness to investigate complex issues
  • At least 3 years of experience in a process support function at a GMP production facility and/or QS/QK
  • Demonstrated process know how (pharmaceuticals, GMP, regulatory aspects)

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note: 

  • Only applications sent via our online form shall be considered.
  • Only Candidates with the right qualifications and relevant experience shall be shortlisted and
  • Incomplete applications shall be rejected.

To apply for this job please visit qsourcingservtec.applytojob.com.