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Head of Production / Stem Cell Senior Technician
☞ PharmiWeb.jobs: Global Life Science Jobs
View: 144
Update day: 22-04-2024
Category: Marketing / PR Printing / Publishing
Industry: Staffing Recruiting
Position: Director
Job type: Full-time
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Job content
Swiss Bioscience GmbH is a rapidly developing GMP manufacturing biotechnology company focusing on the production of human mesenchymal stem cells, we are passionate about our mission to improve and extend the lives of people by developing call-based treatments for regenerative medicine applications, we are in the Zurich Area, Switzerland.We are seeking a Head of Production/Senior Technician to oversee and manage our stem cell production operations. The successful candidate will be responsible for ensuring that our production processes are efficient, compliant, and deliver high-quality stem cell products.Responsibilities- Oversee all aspects of stem cell production, including scheduling, equipment maintenance, inventory management, and quality control
- Ensure compliance with GMP regulations and maintain a clean room environment
- Establish and maintain departmental procedures and practices to ensure efficient operation and continuous improvement
- Ensure compliance of QC Laboratory and QA Compliance activities (e.g., environmental monitoring, equipment, and utility qualification, SOPs, cleaning validation, validation protocols/reports creation and review)
- Prepare and cryopreserve stem cell products according to defined protocols
- Conduct investigations and risk assessments to support deviations and change controls
- Write, review, and manage internal quality system SOPs and other GMP regulatory-related documentation
- Approve specifications sampling instructions, test methods, and other quality control procedures
- Promote high standards of good laboratory and manufacturing practices
- Provide the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP, and safety regulations
- Manage and train production staff, ensuring that they are properly trained and that all production processes are conducted in a safe and efficient manner
- BSc/MSc in Pharmacy, Cell Biology, Biomedical Science, or a relevant discipline.
- At least 2 years of experience in life sciences or similar ISO/GMP environment
- 3 years of proven experience in aseptic work
- 3 years of proven experience with validation and equipment qualification processes
- Previous experience with adherent cell cultures in a highly regulated industry is a strong asset
- Hands-on experience with an automated microbial detection system and flow cytometry will be a plus
- Very good MS Office and documentation skills
- Ability to communicate and document in English, and German is a strong asset
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Deadline: 06-06-2024
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