GMP Upstream Process Supervisor

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 Upstream Process (USP) Supervisor . This position will report directly to the Head of Manufacturing. As GMP USP Supervisor, 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 Upstream operations, including mammalian cell culture, bioreactor management, and aseptic techniques for cell line handling.
• Manage buffer and media preparation, powders, and liquids for internal supply, ensuring compliance with GMP standards.
• Handle single-use technologies, including materials management, closed systems, and aseptic connectors, welding, and sealing.
• Contribute to technology transfer and scale-up processes as needed.
• Prepare, review, and manage GMP documentation, including manufacturing batch records, SOPs, and risk analyses, with an emphasis on electronic batch records and paperless environments.
• Troubleshoot and resolve upstream manufacturing issues, conduct root cause analysis, and plan sector activities effectively.
• Adapt to new technologies and implement innovative methods to enhance efficiency and production effectiveness.
• Manage timelines and resources to meet company milestones, while providing training and guidance to staff on operational and compliance procedures.

Qualifications:

Expertise

• Degree in biotechnology, bioprocess engineering, or related field.
• 3-5 years of experience in pilot or commercial production of biotechnological products in the USP sector; experience with Advanced Therapies Medicinal Products is a plus.
• Familiarity with QbD, cGMP, and commercial manufacturing requirements; experience in process and equipment qualification is desirable.
• Proficient in Sartorius BioPat MFCS software, SCADA interfaces, and Microsoft Office Suite.
• Experience in equipment and process qualification and validation from a production perspective.
• Fluent in English; German is a plus.

Personal Skills

• Strong organizational skills, detail-oriented, and capable of working autonomously to meet timelines.
• Effective problem-solving skills, including troubleshooting and root cause analysis for manufacturing issues.
• Excellent communication and collaboration skills, with the ability to represent the sector in cross-functional forums.
• Adaptable to evolving technologies and processes, with a focus on innovation and continuous improvement.
• Team-oriented mindset.

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 an 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 creative freedom.

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

Manufacturing and Science

Industries

Pharmaceutical Manufacturing

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