Aseptic Production Associate
etherna
General job descriptionThe 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.Responsibilities and DutiesThe 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 andGMP requirementsMaintain the production area according to the procedures and instructions,Follow training in adequacy with the functionPerform on regular intervals routine maintenance, calibration, qualification activitiesWarn the supervisor in case of problems, analyze the data, help in troubleshooting and propose technical solutionsAssist in the development and implementation of new techniquesAssist in the technology transfer from third parties (customers and/or development partners)Draft production procedures, report forms and protocolsEnsuring inspection-readinessJob requirementsEducation: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 biologyBroad technical expertise and mastering of several laboratory techniques.Knowledge of good manufacturing practices (GMP) and/or lab quality assurance practices is a plusOther Qualifications, Skills and Abilities:Detail-oriented and accurate in following instructions, record keeping and completion of reportsAffinity with GMP guidelines and working in a quality-oriented environment.Able to perform experimental troubleshooting and propose technical solutionsGood organizational capacities and detailed documentation practicesGood knowledge of EnglishGood communication skillsWell organized, well-structured, hands-on, result focusedAble to work under stringent timelinesAbility to foster teamwork and a collaborative atmosphereEnthusiastic, flexible and able to multitaskUnderstanding of MS Office (Excel, Word, PowerPoint, Outlook)Our offerAn exciting job in a dynamic and entrepreneurial environment with room for personal development.Work within an innovative environment where you can learn a lotEmployment contract of unlimited duration with a competitive salary package.Working in a fun team where collaboration, growth but above all fun are central
Niel, Antwerpen
Wed, 11 Dec 2024 23:46:52 GMT
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