GMP Downstream Process
Vor 3 Tagen
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 13,000-square-foot R&D facility running and building a new 26,000-square-foot 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 Downstream Process (DSP) Operator. As GMP Operator 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:
- Perform GMP downstream operations, including normo-flow and tangential-flow filtration, chromatography purification techniques, and single-use equipment.
- Support buffer preparation and manage powders and liquids for internal supply.
- Handle single-use technologies, including materials management and closed systems using aseptic connectors, welding, and sealing.
- Ensure compliance with GMP standards and generate relevant GMP documentation; support electronic batch records if applicable.
- Troubleshoot and help resolve issues during downstream manufacturing processes.
- Maintain flexibility and adaptability to evolving technologies and processes while fostering innovation in production methods.
- Follow established workflows and best practices for gene therapy production and facility operations to ensure uninterrupted operations.
Qualifications:
Expertise
- Degree in biotechnology, bioprocess engineering, or related field is desirable but not mandatory.
- At least 2 years of experience in pilot or commercial production of biotechnological products in DSP; experience with Advanced Therapies Medicinal Products is a plus.
- Familiar with cGMP and commercial manufacturing requirements; experience with qualification and validation of equipment and processes is desirable.
- Proficiency in Cytiva's Unicorn software, SCADA interfaces, and Microsoft Office Suite; experience with SAP and ERP implementation (ideally SAP S4) is preferred.
- Fluent in English; German is a plus.
Personal Skills/Soft Skills
- Detail-oriented with a proactive and adaptable working attitude.
- Effective problem-solving skills, with the ability to identify and resolve manufacturing issues.
- Strong communication and collaboration abilities in cross-functional and team-oriented environments.
- Team-oriented approach, fostering a culture of continuous improvement and operational excellence.
- Flexibility and openness to adopting evolving technologies and innovative processes.
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, including STI component.
- 5 weeks 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 levelAssociate
Employment typeFull-time
Job functionScience and Manufacturing
IndustriesPharmaceutical Manufacturing
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