Biotechnology Process Manager
Vor 2 Tagen
Siegfried DINAMIQS is a leading Contract Development and Manufacturing Organization (CDMO) in Switzerland, specializing in the manufacturing of viral vector gene therapies.
As a GMP Upstream Process Supervisor at DINAMIQS, you will have the opportunity to contribute to the development and implementation of cutting-edge process technologies and innovative solutions for our clients.
The role encompasses a diverse range 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.
To succeed in this role, you will require:
- A degree in biotechnology, bioprocess engineering, or a 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.
You will work in a dynamic environment where you can develop your skills and expertise. As a valued member of our team, you will enjoy a competitive compensation package and benefits that promote work-life balance and employee well-being.
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