Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and is seeking a motivated Manufacturing Engineer to join the growing manufacturing team. If you are interested in this unique opportunity, please submit your application (including a cover letter).
About The Position
We are seeking a highly motivated individual to join us as a Manufacturing Engineer. The Manufacturing Engineer will be part of the manufacturing team and will be responsible for producing stem-cell for clinical and commercial use. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing, and developing company that makes a difference. This role will work closely with cross-functional teams internally (development, manufacturing, QC, CMC, and regulatory). Reporting to the Head of Production, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.
• Support the daily activities in the laboratory and GMP facility
• Support cross-functional activities related to manufacturing, process development
• Manufacturing of drug substances and drug products for clinical and future commercial use in accordance with regulatory requirements
• Execute GMP processes according to production schedules and instructions (e.g., MBR, SOP, and work instructions)
• Comply with company policies and standards, risk assessments, instructions, and protocols to produce stem cells batches
• Prepare, review, and revise GMP documentation
• Participate in tech transfer activities
• Coordinate periodic calibration, and maintenance and act as a superuser for equipment and instruments
• Handling CAPA and initiation of deviation
• Supervise and train team members in cleanroom environments
• Ability to work using a good aseptic technique.
• Good understanding and application of GMP and regulatory requirements.
• Experience in working in GMP for clinical or commercial use
• Good understanding of biological pharmaceutical manufacturing
• B.S in Life science or relevant areas is preferred
• experience of working in a regulated environment, ideally with upstream and/or downstream processes
• Be able to speak/write Swedish and English fluently
• You understand biological manufacturing and testing (R&D and clinical manufacturing)
• You have at least 3 years of experience in the pharmaceutical industry, preferably in biopharmaceuticals
• Extensive GMP knowledge and experience
You are independent, good at driving your work forward and you have a good ability to take initiative. You are a natural leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.
Equal Opportunity Work
At Procella we welcome, and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.