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Process Engineer, Stem Cell Biology

Ncardia is an established, globally operating, stem cell-based drug discovery & cell therapy company. At Ncardia, we believe that stem technology will help get better therapies to patients faster. The company is a supportive and trusted partner for scientists operating within the human induced pluripotent stem cell (hiPSC) drug discovery and cell therapy fields, and in particular, in the cardiovascular and neurology space.

Ncardia develops, produces and commercializes hiPSC based solutions. Our offerings range from concept development to pre-clinical studies, including custom manufacturing of a range of cell types, as well as discovery services such as disease modelling, screening, and safety assays. Manufacturing process development expertise supports the development of cell therapy products.

We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution. Within our manufacturing technology team in Gosselies (Belgium) there is a position immediately available for a Process Engineer, who will report to the Director Manufacturing Technology.

Our internal culture statement promotes Ncardia as an ambitious company expecting from its employees a positive attitude, transparent behavior, respectful communication, with integrity as the most important value.

For more information about the company, please visit our website www.ncardia.com.

Job Description

As a process engineer in Stem Cell Process Development team, your key responsibilities will be in developing cGMP compliant suspension-based and/or adherent culture systems manufacturing processes and in process validation.

In this role you will focus on the automation and scale-up of bio-processes for manufacturing products from pluripotent stem cells to include but not limited to immunotherapy, CAR-T, and NK cells. You'll also provide technical expertise in cGMP cell manufacturing including bioreactors, cell washing and concentration technologies, and fill/finish operations.

As a major part of the job responsibility includes hands on processes development, the preferred candidate is a highly motivated researcher with desire to work in a laboratory-focused role.

You will join an international and dedicated group of scientists, project leaders and laboratory technicians. We have expertise in bioprocess development, stem cell biology, quality system compliance and cell based assays and truly believe that stem cell therapies will make a difference in the lives of patients suffering from chronic diseases. If this awakens your interest, please apply and support us to achieve our mission in bringing better therapies to patients faster.

Tasks and Responsibilities include (but are not limited to):

  • Serve as a key person in stem cell process development.
  • Design and execute studies for the development of novel hiPSC-derived cell types based on QbD principles, including DoE and statistical analysis
  • Develop, optimize and validate processes for iPSC-derived cells manufacturing: automation, scale-up, ensure consistency, reduce cost, and implement cGMP requirements.
  • Develop mid-scale models for process studies. Identify Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).
  • Evaluate and implement Process Analytic Technologies (PAT) for improved monitoring and control of stem cell bio-processes. Apply Quality By Design (QbD), defining quality Target Product Profile (qTPP).
  • Perform risk assessment.
  • Write protocols, technical reports, and Standard Operating Procedures (SOPs).
  • Participate in technology transfer of processes and equipment to the (client) Manufacturing group.
  • Collaborate with project teams (including business development and QA) to integrate processes.

Required experience:

  • Ph.D. in bio-engineering, chemical engineering, or biological sciences, or Master’s degree in a comparable field plus five years of relevant experience
  • Demonstrated proficiency with mammalian cell culture processes - preferably bioreactors
  • Demonstrated ability to work in a fast-paced, collaborative, and matrixed organization environment.
  • Familiarity with generation and interpretation of large datasets
  • Familiarity with risk assessments such as FMEA and designing, streamlining, and characterizing processes in the Quality by Design space
  • Knowledge of regulatory requirements for Good Manufacturing Practices (cGMP)
  • Relevant experience or understanding of the following:
    • Prcess development as a member of product/process development teams.
    • Pluriptent stem cells and/or differentiation
    • Immun-biology, immuno-therapy, and related manufacturing techniques
    • Varius cell and molecular techniques including flow cytometry, Q-RT-PCR, fluorescence microscopy, and high content imaging

Required skills:

  • Strong organizational, troubleshooting and interpersonal skills along with excellent oral and written communication
  • Ability to work a flexible schedule when weekend work is required
  • Experience in maintaining organized and detailed notebook records to support internal documentation needs
  • Since we are working in an international environment; proficiency in English, both written and spoken, is a prerequisite.
  • You are open-minded and a good communicator by nature.
  • You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment, and in a job that requires you to be flexible, take initiatives and think out of the box when challenges occur.
  • You are a true team-player who enjoys working in close collaboration with colleagues in and out of the laboratory.
  • Since we are working in an international environment; proficiency in English, both written and spoken, is a prerequisite.

Job Location: Gosselies

Position Type: Full time

Start Date: Immediately

Offer:

We offer a challenging position in a dynamic biotech company with room for personal growth and development. Depending on your education and experience, we provide an appropriate salary.

Interested:

For questions or further information about this vacancy, please contact Naàlia Marinho (naalia.marinho@ncardia.com).

Send your motivation letter with curriculum vitae by September 30 to: careers@ncardia.com