Siegfried DINAMIQS is a Contract Development and Manufacturing Organization (CDMO) based in Schlieren-Zurich, Switzerland, specializing in the manufacturing of viral vector gene therapies.
At DINAMIQS we are at the forefront of science and innovation. We help our clients improve outcomes and accelerate their gene therapy projects. We offer a comprehensive range of services, including vector design optimization, cutting-edge process development and analytics, as well as manufacturing. With a state-of-the-art R&D facility running and building a new GMP facility, we are dedicated to supporting gene therapy projects with scalable and efficient solutions.
DINAMIQS has become part of Siegfried's global network in 2023 and is now looking to grow its dedicated team of experts by hiring a GMP Aseptic Filling Technician as part of our productive Downstream Process (DSP) team. As GMP Aseptic Filling Technician you will have the chance to shape the future of gene therapy together with the DINAMIQS team and its clients.
If you are a highly motivated, entrepreneurial, outcome-driven individual, eager to advance state-of-the-art gene therapy, you are the person we are looking for.
Your role encompasses a diverse and rich area of responsibilities:
* Operate and qualify GMP Biological Drug Product isolator filling lines, manage single-use materials, and implement aseptic closed systems.
* Ensure GMP Annex 1 compliance, draft and review documentation, and manage MBRs, SOPs, and risk analyses.
* Troubleshoot manufacturing issues, conduct root cause analysis, and resolve deviations.
* Prioritize and plan activities effectively in a structured, proactive manner.
* Ensure regulatory compliance for biologics manufacturing and stay updated on industry trends, technologies, and regulatory changes.
* Adapt to evolving technologies, implement innovative processes, and optimize operational workflows for Drug Product manufacturing.
* Lead process definition, including filling line qualification, risk assessments, and regulatory alignment, becoming the main referent for the sector in the DP activities.
* Identify and mitigate risks to ensure seamless facility operations, align cross-functional teams, resources, and timelines for project delivery.
Qualifications
Expertise
* Degree in biotechnology, bioprocess engineering, or related field with solid experience in the field.
* Minimum of 5 years of experience in Drug Product manufacturing with small-scale isolator embedded filling lines, including qualification, process definition, and initiation; experience with Advanced Therapies Medicinal Products is desirable.
* Familiar with QbD, cGMP, commercial manufacturing requirements, and single-use technologies.
* Proficient in Microsoft Office Suite.
* Fluent in English; German is a plus.
Personal Skills
* Hands-on approach with strong organizational skills and a proactive, structured mindset.
* Problem-solving abilities, including troubleshooting and root cause analysis for manufacturing processes.
* Effective communication skills for cross-functional collaboration and teamwork.
* Flexible and adaptable to evolving technologies and processes, with a willingness to continuously learn and grow.
* Ability to prioritize tasks and manage timelines.
What you can expect
* A unique and amazing work experience, being part of one of the most dynamic, diverse, and inclusive CDMOs in the industry.
* Competitive and attractive compensation.
* 5 weeks of holidays and flexible working hours make it possible to combine family, leisure time, and career.
* Impactful Work: Make a significant difference through innovative gene therapy projects.
* Learning Opportunities: Develop diverse skills in a dynamic environment.
* Fast-Paced Environment: See results quickly and enjoy the creative freedom from joining early in the facility lifecycle.
Are you interested in joining a motivated team with an inclusive and collaborative culture? Then take the next step and send us your application via LinkedIn.
Seniority level
Associate
Employment type
Full-time
Job function
Science and Manufacturing
Industries
Pharmaceutical Manufacturing
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