eTheRNA is an mRNA technology discovery and development company with a full platform of integrated capabilities including: mRNA construct design and optimization; proprietary lipid nanoparticle (LNP) formulations which have demonstrated organ-specific distribution preclinically; process development and manufacturing capabilities for mRNA drug substance (gram GMP scale); and proprietary LNP / final product formulation technologies, including a lyophilized thermostable formulation in advanced development.
With a focus on immune modulation and T Cell stimulation, eTheRNA is pursuing internal development programs to validate its core technologies and enable strategic partnerships in a range of geographic markets and therapeutic areas. eTheRNA is backed by a global syndicate of leading investors and is headquartered in Belgium with offices in New York and Hong Kong.
www.etherna.be | www.ethernamanufacturing.com
General job description
The Aseptic Production Associate is responsible for preparing equipment and materials for production in an aseptic cleanroom environment. According to cGMP requirements, the Aseptic Production Associate will perform routine and specialized laboratory operations in the production of drug substances and drug products. He or she prepares and reviews batch documentation and needs to participate in process deviations while ensuring GMP compliance.
The Aseptic Production Associate is a member of the mRNA production team. This position will be based in Niel.
Responsibilities and Duties
The Aseptic 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 according to cGMP requirements.
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:
Preferably 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.
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 troubleshooting 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 timelines
Ability to foster teamwork and a collaborative atmosphere
Enthusiastic, flexible and able to multitask
Understanding 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 with a lot of extra benefits
Work within a dynamic and fast-growing group with great colleagues