• 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 Production 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, in due time, according to cGMP requirements, to current procedures, to batch records and to supervisor’s instructions.

The Production Associate is a member of the mRNA production team. This position reports into the Operational Manager Production.

This position will be based in Niel.

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
  • 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 materials before use;
  • Maintain 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/to the GMP production team and third parties (including customers and/or development partners);
  • Draft production 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.

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.

QC Manager

General Job Description

The QC manager is responsible for the daily organization, planning and review of lab activities performed by the QC Associates and external contract Laboratories, in due time, in line with business requirements and priorities, in compliance with the current international and Belgian laws, regulations and guidelines in general, as well as cGMP guidelines and the company’s internal standards and procedures. The QC manager manages and coaches the QC Associates and is the direct point of contact for internal departments (mainly Production, Product Development and QA), and external partners, like contract laboratories. He/she works in close collaboration with the QP, Head of Manfacturing, and the CMC Lead/QC SME.

The QC manager position reports into the Head of Manufacturing.

This position will be based in Niel.

Responsibilities and Duties

The QC manager duties shall include, but not be limited to:

  • Primary responsibilities will be to plan and review a variety of routine and specialized laboratory operations in the quality control of mRNA based pharmaceutical drug substances and products according to cGMP requirements and to current procedures and protocols
  • Supervises and coaches the QC Associates and follow-up of their roles & responsibilities and trainings plan
  • Interact very closely with the Production, Product Development, CMC Lead/QC SME and QA teams in order to ensure that production, QC and QA activities are aligned and efficient
  • Works very closely with the CMC Lead/QC SME on all topics requiring an in-depth knowledge of the QC systems, like in case of investigations, OOS, events, stability issues, …
  • Work very closely with the CMC Lead/QC SME and Product development on the implementation of new methods in an operational setting
  • Keeping up-to-date with current laws, regulations and guidelines
  • Keeping up-to-date with QC technology
  • The organization and the planning of the QC lab in order to achieve the analysis of the materials and products in line with production planning and clinical trials requirements
  • The organization and planning of stability studies in line with protocols and timelines for clinical studies
  • Write QC instructions, forms and protocols and organize and perform data analysis and reporting on qualification, environmental monitoring and stability studies
  • Escalates and reports events, OOS, initiates changes and implements CAPA
  • Supports in the performance of internal and external audits

Job Requirements

  • Education:
    • Master with a scientific background

  • Experience:
    • Minimum 8 years of relevant experience (preferably in (bio)pharmaceutical industry)
    • An in-depth knowledge of cGMP standards and practices
    • Good knowledge of bio-analytical quality control methods like qPCR, spectrophotometry, MicroBCA, Elisa, Western blot, Dot blot, …
    • Writing SOPs & Protocol development
    • Experience with internal and external audits
    • Experience with aseptic production and biotech processes is a plus
    • Experience in people management

  • Other Qualifications, Skills and Abilities:
    • Detail-oriented and accurate in following instructions, record keeping and completion of reports
    • Affinity with cGMP guidelines and working in a quality-oriented environment
    • Analytical mind, risk-based thinking, result-focused
    • Scientific Integrity
    • Good organizational capacities
    • Excellent planning and project management skills
    • Detailed documentation practices
    • Good knowledge of Dutch and English
    • Good communication & social skills
    • Well organized, well-structured, hands-on, result focused
    • Able to work under stringent time lines
    • Strong sense of responsibility
    • 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.

Head of (Downstream) Process Development (DSP)

Responsibilities and Duties

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

  • Oversee the Process Development function and be responsible for managing the budget, while delivering on the annual goals
  • Role encompasses development of new processes for existing mRNA products and new processes for new products as part of the product translation team
  • Participate in an expert role in development project teams
  • Ensure strong alignment with the manufacturing, engineering and quality groups
  • Supervise the fast and efficient identification of production methods
  • Direct the establishment and optimization of manufacturing platforms to reduce development costs
  • Ensure the timely generation of documents necessary for appropriate filings at the regulatory authorities
  • Be responsible for the timely transfer of a stable and reliable production process, including all necessary documentation and process descriptions, to the manufacturing group
  • Support third party contract manufacturing service commissions
  • Assess and recommend third party service providers
  • Remain conversant with relevant external technological advances

Job Requirements

  • Education:
    • Masters or Ph.D in life sciences or bio-engineering

  • Experience:
    • A minimum of 5 years of experience in bioprocess development with an emphasis on protein purification and downstream processing
    • Have a good understanding of process-scale chromatography and filtration techniques
    • Several years of managerial experience and leading groups as well as project management of CMC development projects
    • A track record in contributions to manufacturing process identification and optimization
    • 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
    • Ability to attract and develop talent to meet both their career goals and current and future business needs
    • Have a detailed and practical understanding of the safety and GMP requirements of biologics manufacturing
    • Fluency in spoken and written English
    • Formal project management training
    • Operational exposure to an SME environment

  • 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
    • 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.

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.