• 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 and adequately financed 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 in vivo 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? Apply to join our team.

Study Manager

General Job Description

The Study Manager will be responsible for the operational management and oversight of specific clinical studies within eTheRNA’s clinical development program.
The Study Manager will work closely with the Clinical Lead and the CMO to ensure successful completion of all clinical deliverables within the required time frame and budget.
This function reports into the Clinical Lead.


Responsibilities and Duties

The Study Manager’s duties shall include, but not be limited to:

  • Manage all clinical aspects of study from the protocol concept through the clinical study report;
  • Oversee performance of CROs and third party vendors to ensure compliance with study protocol and in accordance with scope of work. Identify areas of concern and escalate to Clinical Lead, CMO and/or CRO as appropriate;
  • Ensure studies are carried out according to study protocol, SOPs and ICH/GCP regulations;
  • Develop and manage the study budget and maintain it within the agreed goals;
  • Establish study milestones;
  • Track and report on progress of study (both study deliverables and budget);
  • Contribute to preparation of study related materials, such as study protocols, informed consent, case report forms;
  • Ensure operational plans are developed, such as recruitment plan, monitoring plan, clinical supplies management, laboratory manual;
  • Ensure that reporting of SUSARs is established and maintained during the study;
  • Ensure identification and selection of investigational sites. Oversee study fee negotiations;
  • Develop an ongoing data review plan to ensure that study objectives are met and determine appropriate action (if needed) in conjunction with study team;
  • Develop and maintain good working relationships with investigators and study staff;
  • Frequent interaction with the cross-functional internal team and external team(s).

Job Requirements

  • Education:
    Master degree in bio-medical sciences (or related) or relevant experience in a similar position in the Biotech/Pharma industry.
  • Experience:
    - A minimum of 2-3 years of experience in managing industry sponsored clinical studies, including management of CRO/external vendors;
    - Experience in managing multi-country studies is a plus;
    - Experience in oncology studies is preferred.
  • Other Qualifications, Skills and Abilities:
    - Quality minded, rigorous, autonomous and customer oriented;
    - Good knowledge of GCP regulations and guidelines;
    - Experience with an electronic data capture system;
    - Able to motivate the internal and external team to work efficiently;
    - Ability to foster teamwork and a collaborative atmosphere;
    - Fluent in English;
    - Well organized, well-structured, hands-on, result focused;
    - Strong management skills;
    - Enthusiastic, flexible and able to multitask;
    - Ability to set priorities and take initiative;
    - Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook).

Offer

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

Production-QC Associate

General Job Description

The Production-QC Associate is a hands-on person and is responsible for the performance of lab activities in the production of mRNA based products in an aseptic clean room environment and QC lab, in due time, according to cGMP requirements, to current procedures, to batch records and to supervisor’s instructions.

The Production-QC Associate is a member of the mRNA production team. This position reports into the Production Lead and the QA/QC Lead.

This position will be based in Niel.

Responsibilities and Duties

The Production-QC Associate 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 and quality control of mRNA based pharmaceutical products (API and vaccines) according to cGMP requirements, to current procedures and to batch records;
  • Inventory management and ordering of laboratory materials;
  • Document and report data and results in accordance with the current procedures and GMP requirements;
  • Check the “conform” status of the equipment and material before use;
  • Clean the production area according to the procedures and instructions,
  • Perform routinely check of the installations and premises;
  • 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 trouble-shooting 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 and QC instructions, forms and protocols.

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.

Lab Technician Pre-Clinical Development

General Job Description

The Lab Technician Pre-Clinical Development is a hands-on person responsible, for in vitro and in vivo tests and investigations in the field of immunotherapy. This position provides also input on the implementation, optimization and validation of new (innovative) methods.

This position reports into the Pre-Clinical Lead.

This position will be based in Jette.

Responsibilities and Duties

The Lab Technician Pre-Clinical Development duties shall include, but not be limited to:

  • Primary responsibilities will be to perform, under general supervision, a variety of routine and specialized laboratory tests and animal experiments, specimen preparations and experimental procedures and will assist in the use of specialized laboratory equipment and analysis of data generated by this equipment:
    • Cell culture of mouse and human cell lines and of murine and human primary cells;
    • Animal (mice) studies (tumor models);
    • Analysis of harvested cells (tumor cells, immune cells) using techniques such as flow cytometry, ELISA, ELISPOT, CTL assay

  • Assist in the development of new techniques/assays;
  • Participate in the maintenance of equipment and lab areas;
  • Maintain appropriate files related to ongoing experiments. Maintain a detailed lab book;
  • Help to troubleshoot experimental techniques, analyzing the data and reporting the experimental results;
  • Inventory management and ordering of laboratory supplies.

Job Requirements

  • Education:
    Professional BS in Laboratory Techniques or related field or equivalent relevant laboratory experience.
  • Experience:
    • Minimum of two years of relevant laboratory experience (can be both academic or industrial);
    • Broad technical expertise and mastering of several laboratory techniques;
    • Experience and interest in animal handling is a must;
    • Working knowledge of good laboratory practices (GLP) and 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;
    • Able to perform experimental trouble-shooting and propose technical solutions;
    • Scientific integrity;
    • 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.

Equipment and Stock Management Associate

General Job Description

The Equipment- and Stock Management Associate will be the technical owner of the cleanroom installation and the production, QC and Immuno-monitoring lab equipment.

The equipment- and stock management associate will work in close collaboration with the Production Lead and his team.

This position reports into the Production Lead.

Responsibilities and Duties

The Equipment and Stock Management Associate duties shall include, but not be limited to:

1. Technical Owner Equipment:
  • Responsible for compliant status of Eguipment (this includes cleanroom installation, production, QC and other lab equipment), and manage maintenance/(re-)validation and calibration planned on time internal or with outsourced external partners;
  • Process owner for the eTheRNA QMS procedural documents related to Equipment management, including Equipment Maintenance and Calibration strategies. (Standard Operating Procedures (SOPs), …);
  • The Technical Owner will review and asses at least monthly the instrument and equipment maintenance and function check records (calibrations, maintenance and other interventions on Equipment);
  • Ensure the Quality Management System (QMS) of eTheRNA is adhered for services on Equipment (this include cleanroom installation, production, QC and other lab equipment);
  • Act as point of contact spokesperson for management of Equipment during internal and external audits;
  • Provide technical input, review and approve Equipment Qualification documents for new or changed Equipment. (Equipment Requirements Specifications, IQ-OQ and PQ Test Documentation,...);
  • Manage Change Controls, related to Equipment;
  • Manage Deviations and Changes related to Equipment e.g. if any procedure and/or policy has not been followed, if Equipment deviate from the established specifications. Execute and implement appropriate corrections, corrective actions and/or preventive actions and document Root Cause Analysis, if required;
  • Execute and implement appropriate corrections, corrective actions and/or preventive actions (CAPA’s) and document Root Cause Analysis, if required;
  • Assures/Performs adequate document filing for Record Retention;
  • Keep track on equipment manuals and spare parts;
  • Monitors key process indicators (KPIs) for the management of Equipment and take action when the KPIs are not met;
  • Ensure appropriate controls and procedures are adhered to ensure reliable data are generated;
  • Acts as Project Leader/Team Member of new projects were equipment is involved;
  • Ensure to have an up to date Job Description, Curriculum Vitae and Training Records.
2. Stock management:
  • Inventory/stock management (overseeing and controlling of the receipt, registration, storage & release of products ordered) for materials used in production/QC and Immunomonitoring laboratory;
  • Maintenance of supplier certificates for materials used in the production/QC and IM laboratory;
  • Overseeing the stock and make adequate inventory to order stock materials on time;
  • Organize the stock with regards to good stock management principles (e.g. FIFO, KANBAN principle,…).

Job Requirements

  • Education:
    Bachelor in Sciences with 4 years of relevant experience, Master in Sciences or Industrial Engineering with 2 years relevant experience or Equivalent by a combination of education and relevant experience.

  • Experience:
       o Full Life Cycle management for equipment, used in a regulated environment;
       o Good knowledge in speaking and writing of Dutch and English;

       o Certifications:
            - Annual exposure to scientific meetings, Workshops, Seminars and Congress (desirable);
            - Project management, e.g. Flawless Project Execution;
            - Health, Safety & Environment trainings (when applicable);
            - Business Conduct trainings (when applicable).

        o Training:
            - Applicable regulatory and compliance requirements (including but not limited to GMP and “GxPs”):
                  • eTheRNA policies, procedures;
                  • Applicable corporate and local environmental, health, and safety requirements.
            - eTheRNA procedural documents related to assigned job responsibilities:
                  •A personal role and task based training plan;
                  •Root Cause Analysis (RCA).
            - Technical topics related to performance of assigned tasks:
                  •Technical knowledge on eTheRNA Equipment.

  • Other Qualifications, Skills and Abilities:
       o Quality minded, rigorous, autonomous and customer oriented;
       o Ability to foster teamwork and a collaborative atmosphere;
       o Communicative;
       o Well organized, well-structured, hands-on, result focused;
       o Enthusiastic, flexible and able to multitask;
       o Ability to set priorities and take initiative;
       o Knowledge 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.