BioLamina is looking for skilled and experienced Downstream Bioprocess Operators to join our dynamic production team. If you are excited about working in the fast-paced biotechnology industry and possess the relevant expertise, we would love to hear from you.

The BioProcess Operator is essential to the production of BioLamina’s high-quality recombinant proteins. With a solid knowledge base, they work both independently and collaboratively, playing an active role in the manufacturing process to ensure superior product quality. The BioProcess Operator’s primary responsibilities include Purification and Fill/Finish operations, key aspects of the downstream bioprocess. They ensure the successful completion of tasks, assigned, within the department´s broader scope.

To meet ISO 9001 and QMS criteria, the manufacturing is carried out in compliance with defined processes, established procedures, and relevant laws and regulations.

Main tasks and responsibilities:

• Carry out downstream production tasks and produce the product according to the production master plan to meet production requirements.
• Perform downstream production tasks, including Midstream, Purification, Finalization, Vial Filling/Labeling, buffer preparations, equipment handling, dishwashing, autoclaving, cleaning, material handling, and providing production support.
• Accurately document all activities in compliance with the Quality Management System (QMS), such as recording events in batch production records (BPRs), logbooks, and stock cards.
• Participate in reviewing batch protocols, investigating deviations, implementing Corrective and Preventive Actions (CAPA), and managing change control processes.
• Regularly update Standard Operating Procedures (SOPs) and BPRs.
• Oversee the management of production systems, including maintaining responsibility for equipment accountability and maintenance.
• Support on-site logistics to ensure smooth operations.
• Actively contribute to continuous improvement efforts within the function.

Education and requirements:

• Higher Vocational Education (YH education) or a comparable degree.
• A minimum of two years of experience as a BioProcess Operator or in a similar role within the pharmaceutical, biotech, or chemical industries.
• A background in laboratory science, with prior experience in purification, filtration processing, and working in LAFs.
• Proficient in computer skills, including Word and Excel.
• Strong written and verbal communication skills in English.
• Excellent collaboration skills and thrive to work in teams.

Merit if you have:

• Experience in the biotechnological production of recombinant proteins, aseptic techniques, and cleanroom practices.
• Hands-on experience with Äkta and other chromatographic systems, as well as protein purification techniques.
• Practical experience with large-scale production processes.
• Familiarity with high-quality systems or GMP (Good Manufacturing Practices).

Personal skills:

We are looking for a reliable individual that works well independently and as part of a team. You are a solid team member who is reliable and have great interpersonal skills. You plan and perform your own work in accordance with department prioritization and goals. You are an active contributor to the continuous development of the department and company.

BioLamina

At BioLamina, you will be part of an international, values-driven organization where dedicated, high-performing colleagues collaborate to make a meaningful impact. We believe our products can change the world, and we have high ambitions to do so. BioLamina is a learning organization, and we do this from each other and from the outside. We value our employees, and we are committed to ensuring that the work environment is pleasant, sustainable, and safe.

We pride ourselves in providing an equal workspace, making sure people are given equal opportunities, equal pay, and are well accepted for their differences. We embrace diversity and inclusion in all aspects of our business.

BioLamina AB is a Swedish biotech company founded on scientific innovations at Karolinska Institutet. Our main products are recombinant laminins, human proteins used to maintain and expand pluripotent stem cells and other primary cell types for subsequent differentiation into specialized cell types. BioLamina is revolutionizing cell culture, and our products are used by researchers worldwide to develop cellular therapies and contribute to the era of regenerative medicine. For further information, please visit: http://www.biolamina.com