Aseptic Production Associate

at  eTheRNA

in Niel
;
etherna provides research and manufacturing excellence by teaming up with highly skilled scientists, researchers and technical experts who are recognized for their contributions to the industry. We acquired substantial intellectual property and know-how over the years that support our exceptional leadership in mRNA and LNP innovation. With a careful balance in our skillset, state-of-the-art facilities and specialized equipment we tackle complex challenges and assure efficiency in our operations.
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 and reports into the Aseptic Production Supervisor. This position will be based in Niel.

EDUCATION:

Professional Bachelor in Laboratory Techniques or Bachelor/Master 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)

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