Upstream and Midstream BioProcess Operators

BioLamina is looking for competent methodical and wellorganized BioProcess Operators to join the team in Flemingsberg. As a member of the production team you will work on creating human recombinant laminins which are marketed as a platform for cultivating various main cell types. Manufacturing is carried out according to specified processes (Suspension cells) established procedures and applicable laws and regulations to satisfy ISO 9001 and QMS standards.

Main tasks and responsibilities:

The BioProcess Operator plays an active role in upstream and midstream production processes applying their expertise while working both independently and as part of a team. They are responsible for completing tasks assigned within the departments broader scope.

• Production of recombinant proteins according to written procedures for which training and certification has been received.
• Suspension cell processes; Upstream and midstream operations media and buffer preparations; equipment handling and cleaning; material handling; 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.
• Identify and participate in deviations investigations Corrective and Preventive Actions (CAPA) and change control processes.
• Regularly update Standard Operating Procedures (SOPs) and BPRs.
• Oversee the management of production systems including maintaining responsibility for equipments and Facility Monitoring System (FMS) oncall responsibility lists.
• Support the logistics onsite ensuring that operations run smoothly.

Education and requirements:

• Higher Vocational Education (YH utbildning) or a comparable degree.
• At least two years working experience as a BioProcess Operator in the pharmaceutical biotech or chemical industries.
• A laboratory science background and/or previous experience of working within upstream and midstream processing.
• Proficient computer skills including Word and Excel.
• Strong written and verbal communication skills in English.

Merit if you have:

• Experience in cell culturing and aseptic techniques.
• Upstream knowledge and practical experience with largescale production processes.
• Background in biotechnological production of recombinant proteins.
• Experience with clean room environments and GMP.
• Proficiency in the Swedish language.

Personal Skills:

We are seeking a reliable individual who excels both independently and in a team. You are a strong team player with excellent people skills and a reputation for reliability. You effectively manage and execute your tasks in alignment with departmental priorities and goals while actively contributing to the continuous improvement of both the department and the company.

Other:

Weekend work and oncall duties may be required.

BioLamina

At BioLamina you will work in an international and valuedriven business working with colleagues who are dedicated and high performing. 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 are dedicated to maintaining a positive sustainable and safe work environment. We take pride in fostering an inclusive workplace where everyone is treated equally with equal opportunities fair pay and respect for individual differences. Diversity and inclusion are integral to 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.

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