• 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? Send us your spontaneous application.

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

This position reports to the QA Manager.

Responsibilities and Duties

The Quality Assurance Senior 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.

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.