This is not just another expert role, it’s a foundational opportunity to co-establish a new Cell Banking Department at one of the largest biosimilar manufacturing investments in Europe. You will play a critical role in setting up GMP-compliant cell banking processes and infrastructure, including documentation systems, digital tools, and procedures required for regulatory approval.
If you bring hands-on experience with Master and Working Cell Banks, knowledge of frozen culture techniques, and a solid background in GMP environments, this is your chance to make a lasting impact in the field of biosimilars.
We offer:
- Employment at Slovenia’s most reputable employer
- Permanent contract
- Competitive salary and annual bonus
- Hybrid working model
- Relocation support if needed
- Pension scheme and employee recognition programs
- Health & well-being support via the “Energized for Life” initiative
- Unlimited access to learning and development opportunities
Main tasks:
- Provide front-line expert support for complex technical issues related to cell banking processes
- Act as Subject Matter Expert (SME) for Master Cell Banks (MCB), Working Cell Banks (WCB), and associated methodologies
- Define and implement process descriptions, workflows, and written procedures for cell banking
- Lead technology transfers, method establishment, and new system implementations from scratch
- Ensure alignment with GMP, cGMP, SOP, HSE, and other regulatory requirements
- Prepare cell banks and coordinate with external laboratories for testing (e.g. viral clearance, identity testing, viability)
- Participate in gap and risk assessments, follow up on corrective and preventive actions
- Support the implementation of automated liquid handling systems (e.g. robotics for cell handling)
- Ensure inspection and audit readiness for cell bank operations
- Mentor and train junior staff; share best practices and maintain technical knowledge flow within the team
We expect:
- Minimum 5 years of experience in a GMP-regulated environment, ideally in biopharma manufacturing or quality
- Demonstrated expertise in cell banking (not just cell culture), including work with frozen cell lines, cryopreservation, nitrogen storage tanks, and cell bank preparation – preferred but not mandatory
- Degree in Engineering, Biotechnology, Pharmacy, Chemistry, or related life sciences (MSc preferred)
- Strong knowledge of GMP, pharma regulatory frameworks, and process validation
- Familiarity with digital manufacturing systems (e.g. SPA, PAS-X, automated handlers)
- Fluent in English (Slovenian is an asset)
- A proactive, structured mindset with the ability to drive implementation in a non-routine, project-phase environment
Kariera
Za iskalce
Podjetje
Kariera d.o.o.
Dunajska cesta 165,
1000 Ljubljana