Manufacturing Engineer (stem-cell products), Procella Therapeutics AB

At Procella Therapeutics (part of Smartcella Holding AB) we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have globally licensed cardiac stem cell therapy in clinical stages (in strong collaboration with AstraZeneca) and a growing pipeline of life changing stem cell therapies.
We are now seeking motivated Manufacturing Engineers, for permanent positions, to join the growing on-site manufacturing team in Tullinge, Stockholm.
About The Position
As Manufacturing Engineer you will be responsible for producing stem-cells for clinical and commercial use. 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 (process development, analytical development, quality and regulatory). Reporting to the Head of Manufacturing & GMP Facilities, this full-time position is located at Procella Headquarters in Tullinge, Stockholm.
Responsibilities
Support the daily activities in the laboratory and GMP facility
Support cross-functional activities related to manufacturing and 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). The work includes some weekend work and on-call duty.
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

Skills
Ability to work in clean room environments using a good aseptic technique (eg. grade B (A) and in BSC)
Good understanding and application of GMP and regulatory requirements.
Experience working in GMP for clinical or commercial use
Good understanding of biological pharmaceutical manufacturing
Experience with small scale (manual handling) of cell culture in clean room environments is an asset

Qualifications
MSc/BSc in Life science or relevant areas is preferred
Experience of working in a regulated environment, ideally with upstream and/or downstream processes
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

Personal attributes
You are ambitious and able to work independently. You like to take initiatives and perform your activities with high accuracy using a quality-oriented mindset. 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.
This is a unique opportunity and you will be part of a great organization within the SmartCella group. Initial focus is to act hands-on to produce life changing products according to critical quality standards. As the business grows there will be great opportunities for personal development and to take on new exciting projects/roles. You will receive a competitive compensation package including pension-, health covering- and insurance plans including a competitive monthly salary. We welcome, and support diversity and are very proud to be a multicultural workplace. We have an open and transparent working environment and encourage collaboration, where inclusion are important values for us.
Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
Reach out to Markus at markus.dahl@valleyrecruitment.se for questions regarding both the position and company.
About the company
SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 65 employees from more than 20 nationalities.
Homepage: https://www.smartcella.com/procella/