At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and in-house cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages and a growing pipeline of stem cell therapies targeting other therapeutic indicators.

As the QC Analyst you are a technical expert charged with performing and supporting the planning of ongoing lab activities to deliver both the project and your own objectives. You plan and ensure the delivery of your work in a timely manner, as defined by the QC Manager.

Main responsibilities

Perform all lab functions in compliance with cGMP
Follow written procedures and execute QC testing for the following release tests: Flow Cytometry, ELISA, qPCR, Appearance
Provide lab support, including reagent preparation, instrument and facility cleaning and maintenance, order stock and management of laboratory supplies
Support Supply Chain, QC and QA in receipt and release of starting and raw materials and consumables according to written specifications
Identify and report deviations and test failures
Manage incoming samples for release and stability testing
Develop / revise current/new SOPs and other GMP documentation
Ensure training is current for all job functions performed

You will also be involved in Technology Transfer (into Procella, out to collaborators or internally with the Analytical Development team) depending on the prevailing project goals of the company and as defined by the line manager.

Required qualification and competence

Practical experience:

Demonstrable experience with culturing primary cells or cell lines.
Knowledge and understanding of relevant analytical methods such as flow cytometry, qPCR, or ELISA and follow written procedures with close attention to detail.
Working knowledge of the GxP laboratory environment, and equipment associated with testing of biopharmaceutical products.
Fluent in written and spoken English.
Proficient in use of MS Office tools (Word, Powerpoint, Excel, Outlook).
Excellent interpersonal and communication skills, both written and verbal.

Education:

BSc and/or MSc in a relevant subject area with 2+ years’ relevant work experience.

Other meriting experience/competence:

Prior experience in cell and gene therapy product development in an industry setting.

Prior experience working with pluripotent stem cells.

Prior experience working under a quality system.

Project and people management

Experience with pluripotent stem cell biology and differentiation

Knowledge and understanding of bioreactors, bioprocessing equipment, cell sorting.

Knowledge of ICH Guidelines and Eudralex Volume 4 ATMP Guidelines

Quality by Design methodology, and Design of Experiments

Experience with working under GMP
Membership of a professional scientific body

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

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SmartCella is a world-leading biotech 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 70 employees from more than 24 nationalities.

QC Analyst