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Production Process Engineer (M/F)

June 23rd 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

As Process Engineer, you are a core member of the production team and a key expert in customer process development projects and internal initiatives including process development, industrialization and new technology set up to maintain efficiency, reduce cost, improve sustainability and maximize profitability.

Reporting to the Head of production, you are an expert in technology and industrialization with a strong drive to deliver rational and GMP processes.

Main activities include:

  • Develop and optimize manufacturing processes from scratch or based on existing processes: industrialization, scaling-up, technology transfer, implementation of GMP requirements,…
  • Identify, assess and implement new technologies to improve product quality, success rate, reproducibility and/or reduce cost and time of manufacturing processes.
  • Propose and lead internal technology projects aligned with the strategic objectives of the company.
  • Apply Quality by Design (QdB) methodology and Design of Experiments (DoE) approach in development. Assist in defining Target Product Profiles, identifying Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).
  • Ensure proper use and training on new technologies for clients and Masthercell employees; eventually on customer site; you work transversally with the production team.
  • Assess the needs for new equipment, establish URS and select suppliers in collaboration with relevant internal teams.
  • Perform technology watch on the market to maintain level of expertise.
  • Manage cost and time constraints.
  • Perform risk assessments.
  • Provide process documentation and operating instructions.
  • Coach/Support production team for all development/industrialization/ GMP manufacturing activities and, as production front line, support Business and Project Management team for technical discussion with prospects/clients.

 

Candidate profile

OBLIGATORY REQUIREMENTS

  • Engineer, Master degree or relevant experience in Lie Science, Industrial Science or biotechnology.
  • 5-10 years of pharmaceutical/biotech industry experience.
  • Expertise in bioprocess development, QbD and DoE methodology.
  • Knowledge in various cell therapies/culture technologies.
  • Knowledge of best practices for technology development and transfer in cell-based process development and/or equipment development dedicated to cell therapy.

USEFUL REQUIREMENTS

  • Excellent organizational skills and keen attention to detail.
  • Communicates clearly and concisely with diverse audiences, in both oral and written contexts, and is comfortable giving and receiving feedback.
  • Fluency in French en English.
  • Expertise in GMP and Aseptic processing is a plus.
  • Rigorous, passionate, dynamic and excellent team skills.
  • Hands-on problem solving and proactive attitude.
  • Open mind, enthusiastic, sense of innovation and literature reading and update.
     

Offer

  • Full-time position (40h/week).
  • An indeterminate contract.
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment with a convivial atmosphere.

Contact Details

To apply for this job, please send your application on the following link MaSTherCell