SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer® (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.

To our Targeted Deliveries segment, the business unit SmartWise Sweden AB, are we now seeking an Operator/Production Lead, who has a solution orientated mindset and can collaborate with colleagues to achieve production goals. As the first Operator and Production Lead you will participate in setting up the in-house manufacturing of the Extroducer from the start. Over time, more operators will be hired, and your work tasks will also include planning of the other operators’ work.

Key responsibilities and scope of the job

As Operator/Production Lead

• Plan for coming week’s production based on the production schedule and work orders provided by the Operations function.

• Distribute work orders to the production team and on a daily bas overlook that the work progresses according to plan and quality requirements.

• Ensure all relevant documents (work orders, batch records, work instructions) are in place before starting production.

• Monitor and make sure that components and subassemblies are in their right storage location.

• Ensure the production premises are neat and clean and well maintained according to the instructions.

• Monitor and ensure production and test equipment are well maintained and when needed participate in calibration activities.

• Mange the document flow of batch records (DHR:s) from Production to QA Release and back to Production, and execute resulting physical movements of components/subassemblies/products.

• Report deviations in production to QA, and together with Process Engineers, R&D and QA perform root cause analysis to decide on appropriate measures

• When needed participate in updating work instructions and batch record forms.

• Participate in structured and continuous improvement work to reach the next improved state of production.

Qualifications & experience

We believe you need to have:

• Minimum Swedish Upper Secondary school or equivalent education

• Experience working with small, delicate materials used in medical devices or in electronics

• Experience in fine assembly: proficiency in assembling small components with precision, often requiring manual dexterity and patience

• Meticulous work ethic: proven track record of producing high-quality work with minimal defects, emphasizing the importance of precision in every task

• Experience in quality control methods: proficiency in using measurement tools like calipers, micrometers, and other equipment for dimensional checks

• Understanding of Quality Management Systems, e.g. ISO 13485 and other relevant quality standards specific to medical device production

• Troubleshooting skills: experience in identifying and resolving issues that may arise in the production process, especially related to precision and quality

• Analytical thinking: ability to analyze production data and metrics to improve efficiency and accuracy

• Flexibility in techniques: experience adapting to new technologies and methodologies to enhance precision and efficiency in production

General skills & behaviors

You are a skilled communicator who shares information clearly with team members and supervisors to ensure smooth operations. You show flexibility and is willing to adapt to changes in processes, technology, or team dynamics and have an eye for details. To inspect components and finished products meticulously to identify potential defects or deviations is crucial, as well as the ability to maintain accurate records of production processes, inspections, and any issues encountered.

The role also requires proficiency in speaking and writing Swedish and English, experience of working with Microsoft Office (word, excel) and with executing transactions in ERP systems (work orders, goods receipt/issue goods movements, etc.)

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities.