• eTheRNA
  • Join us in our mission to bring hope to patients by developing novel immunotherapies

Careers

eTheRNA has entered a new phase in its young but promising history. The company is well positioned to complete phase I and II clinical studies with its mRNA-based TriMix platform for the treatment of advanced melanoma and breast cancer. eTheRNA plays a pioneering role in the development of mRNA-therapies that deliver tumor antigens to dendritic cells.

eTheRNA groups team members who are all passionate about mRNA technology and who wish to contribute to the development of truly innovative immunotherapies that can help millions of patients by combatting their disease.

Do you share our passion and are you the best in your area? Send us your spontaneous application.

Aseptic Production Associate

General Job Description

The Aseptic Production Associate is responsible for preparing equipment and materials for production in an aseptic clean room environment. According to cGMP requirements, the Aseptic Production Associate will perform routine and specialised laboratory operations in the production of active pharmaceutical ingredient and drug products. He or she prepares and reviews batch documentation and needs to participate in process deviations while ensuring GMP compliance.

Responsibilities and Duties

The Production Associate’s duties shall include, but not be limited to:

  • Primary responsibilities will be to perform, under general supervision, a variety of routine and specialized laboratory operations in the production of mRNA based pharmaceutical products (API and vaccines) according to cGMP requirements, to current procedures and to batch records
  • Document and report data and results in accordance with the current procedures and GMP requirements
  • Maintain the production area according to the procedures and instructions,
  • Follow training in adequacy with the function
  • Perform on regular intervals routine maintenance, calibration, qualification activities
  • Warn the supervisor in case of problems, analyze the data, help in troubleshooting and propose technical solutions
  • Assist in the development and implementation of new techniques
  • Assist in the technology transfer from third parties (customers and/or development partners)
  • Draft production procedures, report forms and protocols
  • Ensuring inspection-readiness

Job Requirements

  • Education:
    • Professional BS in Laboratory Techniques or BS/MS in biology, (bio)medicine or life sciences or related field or equivalent relevant laboratory experience.

  • Experience:
    • Minimum of two years of relevant laboratory experience (can be both academic or industrial) in the field of immunology and cell biology
    • Broad technical expertise and mastering of several laboratory techniques;
    • Working knowledge of good manufacturing practices (GMP) and/or lab quality assurance practices is a plus

  • Other Qualifications, Skills and Abilities:
    • Detail-oriented and accurate in following instructions, record keeping and completion of reports;
    • Affinity with GMP guidelines and working in a quality-oriented environment;
    • Able to perform experimental trouble-shooting and propose technical solutions;
    • Good organizational capacities and detailed documentation practices;
    • Good knowledge of English;
    • Good communication skills;
    • Well organized, well-structured, hands-on, result focused;
    • Able to work under stringent time lines;
    • Ability to foster teamwork and a collaborative atmosphere;
    • Enthusiastic, flexible and able to multitask;
    • Understanding of MS Office (Excel, Word, PowerPoint, Outlook).

Offer

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development;
  • Employment contract of unlimited duration with a competitive salary package.
  • Working in a nice office with nice colleagues between Antwerpen and Mechelen

Process Development Associate

General Job Description

The Process Development Associate will be responsible for execution of hands-on process and analytical development work at the eTheRNA site in Ghent and Niel.

Responsibilities and Duties

The Process Development Associate’s duties shall include, but not be limited to performing, under general supervision, a variety of laboratory tests and experimental processes:

  • Assist in development, optimization and qualification of new techniques, processes and assays
  • Mainly focused on development of functionality/potency assays using in vitro cell culture, cell transfection, bio-assays, flow cytometry, ELISA, ELISPOT, Luminex, Western Blot, SDS-PAGE, AGE/CGE and other methods
  • Participate in lab supply ordering, (patient) sample receipt, inventory management, biobanking maintenance of equipment and lab areas
  • Data processing, data analysis and good documentation practices using electronic lab notebook, protocol- and report writing; assistance in troubleshooting experimental techniques

Job Requirements

  • Education:
    • Bachelor’s in biotechnology/laboratory science or MS in biomedical sciences or similar

  • Experience:
    • Minimum of 1-2 years of relevant experience in academic or biotech industry in a similar function.
    • Broad technical expertise and mastering of several laboratory techniques including cell culture and molecular biology
    • Working knowledge of good (clinical) laboratory practices and lab quality assurance is a plus

  • Other Qualifications, Skills and Abilities:
    • Detail-oriented and accurate in following instructions, record keeping and completion of reports
    • Able to perform experimental trouble-shooting and propose technical solutions.
    • Scientific integrity
    • Ability to work collaboratively and communicate effectively with internal teams.
    • Fluent in English;
    • Well organized, well-structured, hands-on, result focused;
    • Able to work under stringent time lines
    • Enthusiastic, proactive, flexible and able to multitask;
    • Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook)
    • Willing to work several days a week during the first months of employment from Ghent, then mainly from Niel

Offer

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development;
  • Employment contract of unlimited duration with a competitive salary package.
  • Working in a nice office with nice colleagues

LNP Formulation Associate

General Job Description

The Formulation Associate will be responsible for the characterization of nanoparticles at the eTheRNA site in Ghent (and occasionally in Niel).

Responsibilities and Duties

The Formulation Associate’s duties shall include, but not be limited to performing, under general supervision, a variety of laboratory tests and experimental processes:

  • Preparation of lipid nanoparticles (LNPs) incorporating mRNA
  • Nanoparticle characterization using dynamic light scattering and zeta-potential measurements
  • Analytical techniques such as spectrophotometry, capillary gel electrophoresis, Western blot, ELISA, RiboGreen RNA quantification, extraction of mRNA from LNPs
  • In vivo immunogenicity and anti-tumor efficacy experiments in mice
  • Data processing, data analysis and good documentation practices using electronic lab notebook, protocol and report writing

Job Requirements

  • Education:
    • Bachelor’s in biotechnology/laboratory science or MS in biomedical sciences or similar + FELASA B or C certificate

  • Experience:
    • Minimum of 1-2 years of relevant experience in academia or industry
    • Broad technical expertise and mastering of several laboratory techniques
    • Working knowledge of good (clinical) laboratory practices and lab quality assurance is a plus

  • Other Qualifications, Skills and Abilities:
    • Detail-oriented and accurate in following instructions, record keeping and completion of reports
    • Able to perform experimental trouble-shooting and propose technical solutions.
    • Scientific integrity
    • Ability to work collaboratively and communicate effectively with internal teams.
    • Fluent in English;
    • Well organized, well-structured, hands-on, result focused;
    • Able to work under stringent time lines
    • Enthusiastic, proactive, flexible and able to multitask;
    • Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook)

Offer

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development;
  • Employment contract of unlimited duration with a competitive salary package.
  • Working in a nice office with nice colleagues

Downstream Process Scientist

General Job Description

The Downstream Process (DSP) Scientist will be responsible for development of new downstream processes for existing and new mRNA products as part of the Process Development team at the eTheRNA site in Niel. He/she works in close collaboration with the Process Development team, reports to the Senior Director Process Development, and works cross-functionally with the preclinical, production, QC team.

Responsibilities and Duties

The DSP Scientist’s duties shall include, but not be limited to:

  • Establish fast and efficient identification of downstream purification methods (filtration, column purification, diafiltration,…) which are amenable to GMP requirements
  • Establish and optimize downstream process platforms to improve product purity and reduce development/manufacturing costs
  • Deliver small scale downstream purification solutions to enable research grade mRNA manufacturing needs for preclinical studies
  • Ensure phase appropriate development and qualification of downstream processes in terms of:
    • Process definition (critical process parameters and critical quality attributes)
    • Risk assessment
    • Requirements for early stage clinical manufacturing compliant with GMP (materials, process, single use disposables, cleaning, …)
  • Ensure timely generation of development plans, protocols and reports
  • Be responsible for the timely scale up and transfer of a stable and reliable downstream process, including all necessary documentation and process description to the GMP manufacturing group
  • Support third party contract manufacturing service commissions
  • Remain conversant with relevant external technological advances
  • Participate in an expert role in PD projects

Job Requirements

  • Education:
    • Master/PhD in biotechnology/bio-engineering/life sciences

  • Experience:
    • Several years of experience in bioprocess development with an emphasis on protein purification or downstream processing. Will have hands-on experience with scale up and large-scale chromatography
    • Ability to address issues of scale-up and process optimisation (from a time and cost perspective), to create new and better ways for the organisation to be successful
    • Experience with single use disposables is an asset
    • Experience with Akta Pilot chromatography skid and Unicorn software
    • Working knowledge of safety and GMP requirements of biologics manufacturing

  • Other Qualifications, Skills and Abilities:
    • Detail-oriented and accurate in following instructions, record keeping and completion of reports
    • Able to perform experimental trouble-shooting and propose technical solutions.
    • Scientific integrity
    • Fluency in spoken and written English is a must
    • Ability to work collaboratively and communicate effectively with internal teams.
    • Well organized, well-structured, hands-on, result focused;
    • Able to work under stringent time lines
    • Enthusiastic, proactive, lead by example, flexible and able to multitask;
    • Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook).

Offer

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development;
  • Employment contract of unlimited duration with a competitive salary package.

Senior Scientist mRNA Formulation

General Job Description

The Senior Scientist mRNA Formulation will join the non-clinical team focused on the design and formulation of new mRNA-based immunotherapies. He/she will report into the [Principal Scientist Non-Clinical Development].

This position is based in eTheRNA’s laboratorium in Gent – Belgium.

Responsibilities and Duties

The Senior Scientist’s duties shall include, but not be limited to:

  • Planning and supporting projects to develop RNA delivery technology;
  • Development and characterizing of novel lipid and/or polymer based mRNA formulations;
  • Theoretical and practical drafting of scientific issues and matters relating to patent law in preclinical cellular and animal-experimental systems;
  • Drive scientific and technical innovation;
  • Lead a team of scientists and technicians and have an active role in the operations of the non-clinical team;
  • Technical staff training;
  • Manage multiple projects in mRNA delivery/formulation research involving cross-functional collaboration within therapeutic areas and across departments. Provide scientific expertise, guidance and strategy to successfully bring programs to Go/No Go decisions;
  • Development of relationships with pre-clinical contract research organizations and contract manufacturers, as well as managing collaborations with other (academic and industry) research centers;
  • Participate in authorship of scientific publications and patent applications;
  • Presenting results internally and externally.

Job Requirements

  • Education:
    • PhD in a life science-oriented discipline (e.g. chemistry, pharmacy, engineering) with a sound knowledge of the specialist aspects and methods involved in biochemistry, organic chemistry or pharmaceutics, or master's degree plus several years of professional experience or comparable qualification.

  • Experience:
    • 3+ years of relevant experience in companies engaged in biotech and/or pharmaceutical development;
    • Excellent knowledge of lipid-based formulation systems;
    • Deep knowledge on the design, physicochemical characterization and evaluation of nucleic acid delivery systems
    • Demonstrated track record of independent critical thinking and scientific achievement, as demonstrated by high impact publications and patents;
    • History of leading and contributing scientifically to discovery research programs;
    • Demonstrated ability to communicate complex data sets in a clear manner to internal and external stakeholders;
    • Strong analytical, problem-solving, and decision-making skills;
    • Strong academic and industry network in nucleic acid delivery;
    • Technical skills:
      • Experience in nanoparticle formulation (microfluidics, emulsification ..) methodologies and nanoparticle characterization techniques (DLS, zeta potential, chromatography);
      • Preferably experience in polymer and lipid synthesis, purification and characterization
      • Knowledge and/or experience with mRNA and miRNAs, lncRNAs or siRNA.

  • Other Qualifications, Skills and Abilities:
    • Detail-oriented with technical skills;
    • Demonstrated strong management, leadership, organizational and interpersonal skills;
    • Ability to solve problems and execute on initiatives;
    • Ability to work collaboratively and communicate effectively with R&D teams;
    • High level of integrity and dependability with a strong sense of urgency and results orientation;
    • Well organized, well-structured, hands-on, result focused;
    • Ability to foster teamwork and a collaborative atmosphere;
    • Enthusiastic, flexible and able to multitask;
    • Ability to set priorities and take initiative and be pro-active;
    • Fluent in English;
    • Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook).

Offer

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development;
  • Employment contract of unlimited duration with a competitive salary package.

Quality Assurance Senior Associate

General Job Description

The Quality Assurance Senior Associate supports the continuous improvement and maintenance of the Quality Management System (QMS) within the company, under the supervision of the QA Manager, and helps to ensure that all operations comply with international cGMP regulations in general and Belgian laws and regulations in particular, as well as the company's internal standards, and assures the correct detection, reporting and closure of quality events, changes and other types of quality system related events.

Responsibilities and Duties

The Quality Assurance Senior Associate duties shall include, but not be limited to:

  • Review and approval of the blanco batch records and batch related labels
  • Perform batch review & follow-up release of batches
  • Prepare Batch Release certificates
  • QA Review & Follow up of events, OOS, CAPA, change requests
  • Assess and evaluate the correctness and completeness of impact and risk assessments
  • Documentation management: keep quality records and files accordingly, revision of SOPs, reports, batch records and other documents related to the QMS, follow-up of electronic document management system
  • Establishes product quality documentation system by writing and updating quality procedures
  • QA Review of:
           - Environmental monitoring activities
           - Stability protocols & reports
           - Validation protocols & reports
  • Execution and participation on QA overview activities
  • Execution and participation on Internal audits
  • Keep training files up to date and inform about training status
  • Release of incoming materials
  • Release of autoclaved materials
  • Create and update QA SOPs
  • Prepare and give QA trainings
  • Assure that good distribution practices are applied on incoming and outgoing goods
  • Record and produce meeting minutes for staff meetings and audits
  • Prepare annual product quality reviews
  • Prepare management review documentation
  • Collect internal and external data from various sources to generate reports for quality review
  • Perform supplier qualification and requalification including audits
  • Perform customer qualification and requalification
  • Assist in the planning and execution of the Validation Master plan:
  • Assist in QA and development related projects
  • Other duties as assigned

Job Requirements

  • Education:
    • Master degree, by preference in biomedicine, life sciences, pharmaceutical chemistry or equivalent relevant experience.

  • Experience:
    • Minimum of 3 years of relevant professional experience with QA work
    • Working experience with a QMS, by preference in pharmaceutical environment, and GMP principles

  • Other Qualifications, Skills and Abilities:
    • Analytical mind, with focus on quality and eye for detail
    • Good data management skills: detail-oriented and accurate in following instructions, record keeping and completion of reports
    • Scientific integrity
    • Good knowledge of English and Dutch
    • Good communication skills (both oral and written)
    • Well organized, well-structured, hands-on, result focused
    • Able to prioritize work, to manage multiple tasks and to work under stringent time lines
    • Ability to foster teamwork and a collaborative atmosphere
    • Enthusiastic, flexible and able to multitask
    • Good understanding and use of MS Office (Excel, Word, PowerPoint, Outlook)

Our Offer

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development
  • Employment contract of unlimited duration with a competitive salary package
  • Working in a nice office with nice colleagues between Antwerpen and Mechelen