• 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.

Research Associate 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 methods.

This position reports into the Principal Scientist, preclinical development.

This position will be based in Ghent.

Responsibilities and Duties

The Research Associate Pre-Clinical Development duties shall include, but not be limited to:

  • Perform, under general supervision, a variety of routine and specialized laboratory tests and animal experiments, specimen preparations and experimental procedures, assist in the use of specialized lab equipment and analysis of data generated by this equipment
  • Generation and characterization of formulations for mRNA delivery
  • Mice manipulations including injections (intravenous, intraperitoneal, subcutaneous), blood collection, induction of tumors and in vivo imaging
  • Analysis of harvested cells using techniques such as flow cytometry, ELISA, ELISPOT
  • Cell culture of human and murine cell lines and primary cells
  • Assist in the development of new assays
  • Help to troubleshoot experimental techniques, analyzing the data and reporting the experimental results
  • Maintain a detailed electronic lab book related to ongoing experiments
  • Participate in the maintenance of equipment and lab areas

Job Requirements

  • Education:
    • Professional Bachelor in Biomedical Laboratory Techniques or Master in Biomedical Sciences/Biotechnology or related field or equivalent relevant laboratory experience

  • Experience:
    • Minimum of two years of relevant laboratory experience (can be both academic or industrial)
    • Experience in cell culture and immunological assays
    • Experience in flow cytometry
    • Broad knowledge of molecular biotechnology techniques (cloning, DNA/RNA isolation, RT-QPCR, Western Blot)
    • Prior experience and interest in animal handling (FELASA B certificate mandatory)

  • Other Qualifications, Skills and Abilities:
    • Detail-oriented and accurate in following instructions, record keeping and completion of reports
    • Able to perform experimental troubleshooting and to propose technical solutions
    • Scientific integrity
    • Proficient in written and spoken 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.

Formulation and filling expert

General Job Description

Formulation and filling expert is a member of the Manufacturing team. This position reports into the [Head of development]. He/she is accountable for formulation process technological transfer from preclinical, formulation process development, upscaling the fill/finish process and improvement and follow up of contractors.

This position is based in Niel.

Responsibilities and Duties

The Formulation and filling expert duties shall include, but not be limited to:

  • Leads formulation and fill/finish process development and the implementation in a GMP setting. Supports the transition of these processes from prototype to full production, in-house and together with contractors;
  • Designs and develops formulation and filling processes for manufacturing and associated validations using principles of process excellence;
  • Defines deliverables and requirements to preclinical team for stage gate review prior to transfer technology to formulation process development
  • Involved in process improvement, process optimization, technology transfer, upscaling and process validation activities to meet agreed-upon objectives and regulatory requirements;
  • Provides support in manufacturing decision-making information by calculating production, labor, and material costs;
  • Develops, writes, and reviews technical and quality system documents;
  • Perform and support the required quality risk assessments in the manufacturing environment;
  • Supports the manufacturing organization in creating the necessary documentation and providing training as a result of new processes or process improvements;
  • Provide hands on support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures. Collect and analyze data to make data driven recommendations/decisions;
  • Build and maintain successful cross-functional relationships within the company;
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Job Requirements

  • Education:
    • Engineering degree in Biotechnology/Biochemistry, Industrial Pharmacist, BS/MS in biology, (bio)medicine, life sciences or equivalent (process industry).

  • Experience:
    • Minimum of eight years of relevant GMP experience (preferably hands-on experience in a bio-manufacturing environment);
    • Minimum five years of relevant experience in process development
    • Broad process technological expertise.
    • Experience in lipid nanoparticle technology is a plus
    • Experience in freeze-drying 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. Experience in aseptic process manufacturing and process validation is a plus;
    • Able to perform experimental trouble-shooting and propose technical solutions;
    • Analytical and solution oriented mindset;
    • Good organizational capacities and detailed documentation practices;
    • Training in Six Sigma and Lean Manufacturing a plus;
    • Project management skills are a plus
    • 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.

Quality Assurance Associate

General Job Description

The Quality Assurance 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

This position reports to the QA Manager.

Responsibilities and Duties

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

  • Printing of the blanco batch records and batch related labels
  • Review of the master blanco batch records
  • Perform batch review & follow-up release of batches
  • Prepare Batch Release certificates & CoA’s
  • 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 and distribution and archiving of SOPs, reports, batch records and other documents related to the QMS
  • Establishes product quality documentation system by writing and updating quality procedures
  • QA Review of:
  •            Environmental monitoring activities
  •            Stability 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
  • Perform Line Clearances
  • Release of incoming materials
  • Release of autoclaved materials
  • Alarm handling
  • 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
  • Preparation of the annual product quality review
  • 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)

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.

Purchase and inventory Manager

General Job Description

The Purchasing and inventory Manager is responsible for sourcing equipment, goods and services and managing vendors, mainly related to the manufacturing and R&D activities. The Purchasing and inventory Manager will perform strategic and other procurement activities across multiple categories of spend, search for better deals and find more profitable suppliers, and secure an optimal inventory level from cost and availability perspective.

The Purchasing and inventory Manager will work in close collaboration with the Manufacturing and Preclinical teams and will also provide purchasing support to other teams in the Company. Where necessary from budget perspective, the Purchasing and inventory Manager will work closely with the Finance and Legal experts of the Company.

Responsibilities and Duties

The Purchasing and inventory Manager’s duties shall include, but not be limited to:

  • forecast levels of demand for services and products
  • secure an optimal inventory level from cost and availability perspective
  • develop and/or implement systems for optimal stock level securement
  • determine quantity and timing of deliveries
  • conduct research to ascertain the best products and suppliers in terms of best value, delivery schedules and quality
  • keep a constant check on stock levels in close collaboration with the Lab Maintenance & Stock Assistant
  • liaise between suppliers, manufacturers, relevant internal departments and customers
  • build and maintain good relationships with new and existing suppliers
  • negotiate and agree contracts, monitoring the quality of service provided
  • work with the quality assurance department to set up quality improvement programs with suppliers
  • work with the quality department to set up sampling programs
  • keep contract files and use them as reference for the future
  • develop strategies to make sure that cost savings and supplier performance targets are met - or exceeded
  • undertake value for money reviews of existing contracts and arrangements
  • forecast price trends and their impact on future activities
  • develop a purchasing strategy
  • partner with internal stakeholders to ensure clear requirements documentation
  • monitor and forecast upcoming levels of demand
  • produce reports and statistics on spending and saving
  • evaluate bids and make recommendations, based on commercial and technical factors
  • ensure suppliers are aware of business objectives
  • assess, manage and mitigate risks
  • attend meetings and trade conferences
  • train and supervise the work of other members of staff

Job Requirements

  • Education:
    • Bachelor/master in supply chain management, logistics, finance, business administration or equivalent

  • Experience:
    • Minimum 5 years’ experience in the procurement of materials/equipment/supplies and the development and review of contracts
    • Proven working experience as purchasing manager
    • Familiarity with sourcing and vendor management
    • Certification in procurement and/or contract administration is a plus

  • Other Qualifications, Skills and Abilities:
    • Good knowledge in speaking and writing of Dutch and English
    • Quality minded, rigorous, autonomous and customer oriented
    • Ability to foster teamwork and a collaborative atmosphere
    • Solid judgement and sound decision making skills
    • Skilled at negotiation and networking
    • Good communication skills
    • Well organized, well-structured, hands-on, result focused
    • Able to work under stringent time lines
    • Enthusiastic, flexible and able to multitask
    • Ability to set priorities and take initiative
    • 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.

Production Manager

General Job Description

The Production Manager is responsible for the day-to-day mRNA production activities of the company. The GMP production is in the first place focused on the manufacturing of mRNA based investigational medicinal products for eTheRNA’s clinical development program but includes also the manufacturing of mRNA products for third parties and other purposes.

The Production Manager is responsible for the day-to-day organization, planning and managing of the production team and production activities in the facility in Niel to achieve safe, efficient and economical production within established manufacturing costs and timelines and to maintain the highest standards of quality (including GMP).

He/she supervises, manages and coaches the Aseptic Production Associates who perform the effective production activities in the aseptic clean room environment. He also participates in the production activities if needed.

He/she works in close collaboration with the Head of Manufacturing, the QP, QC Manager and QA Manager.

The Production Manager reports to the Head of Manufacturing.

Responsibilities and Duties

The Production Manager duties shall include, but not be limited to:

  • Is responsible for the day-to-day organization and operations of the production according to the GMP requirements, process requirements, production related SOPs and in due time according to the production schedule
  • Is responsible for the production planning and scheduling and key operating metrics
  • Is responsible for the ensuring that all starting materials and equipment needed for the production are availability in due time in close collaboration with the inventory and purchase responsible person(s)
  • Supervises, coaches and develops the Aseptic Production Associates
  • Is fully trained to participate in the production activities if and when needed
  • Is responsible for the maintenance of environment and hygiene of the production clean rooms according to the general schedule
  • Drives safety and quality throughout his/her team
  • Verifies the production documents completion and conformity before final verification by the QA department and QP
  • Interacts very closely with the QC and QA teams in order to ensure that production, QC and QA activities are aligned and efficient
  • Escalates and reports deviations, initiates changes and implements CAPA
  • Assists with the automation and continuous process and quality improvements
  • Drives and leads 5s and operational excellence projects
  • Assists in the project follow-up of third party customer production orders
  • Participates in and drives cost reduction programs
  • Represents the production department in construction projects related to the production unit

Job Requirements

  • Education:
    • - Bachelor or Master degree in a life science, engineering, applied science, … or related field

  • Experience:
    • Minimum 8 years of directly related industry experience, including minimum 4 years in a proven operational leading role, in a cGMP regulated environment
    • An in-depth knowledge of cGMP standards and practices
    • Experience in working in an aseptic production environment
    • Experience with biotech processes is a plus

  • Other Qualifications, Skills and Abilities:
    • Strong leadership skills and having the ability to energize, mobilize, inspire and passionate a team
    • Ability to foster teamwork and a collaborative atmosphere
    • Hands-on person with a pragmatic and analytical mindset. Well organized, well-structured, and result focused
    • Hands-on mentality, well organized
    • Driven by continuous improvement and efficiency
    • Strong quality/compliance mindset
    • Good communication skills
    • Fluent in Dutch and good knowledge of English
    • Able to work under stringent time lines
    • Enthusiastic, flexible and able to multitask
    • Good 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.