Manufacturing Engineer

Procella Therapeutics AB hasadvancedcapabilities within stem cell therapy development and inhouse cGMP manufacturing. Globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

We are now seeking highly motivated individuals to join us as a Manufacturing Engineers.

About The Position

As Manufacturing Engineer youwill be responsible for producingstemcell 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, qualityand 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, 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). Thework 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 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

Qualifications

• 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

Personal attributes

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.

Diversity & Inclusion

We welcome, and support diversity and are very proud to be a multicultural workplace. To have an open and transparent working environment and encourage collaboration and inclusion are important values for us.

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.