Snabbfakta

    • Stockholm

Ansök senast: 2022-10-10

QC Manager to Procella Therapeutics AB

Publicerad 2022-09-19

Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease.  We are seeking a highly motivated individual to join the growing quality team as a QC Manager. Are you a leader skilled in quality control within biological manufacturing with a good knowledge of GMP who want to contribute to creating the next generation of cell-based therapies for patients running out of options? Then this is the role for you! You will be working at a patient-focused, growing and developing company that makes a difference.  

About The Role
As a QC Manager, you will be part of building up Procella’s GMP biochemistry laboratory. You will drive and support the development and successful implementation of the laboratory, including setting resources. As you are the first one in this team, you will have the possibility to build your new team from the beginning. The main responsibilities within the role are ensuring instrument and equipment qualifications, development of SOPs, methods and validation/verification of the analytical methods while ensuring compliance at the outsourced CLOs. This role will work closely with cross functional teams internally (development, manufacturing, CMC and regulatory) where you will act as an expert and be an advisor regarding quality control issues/queries. You will report to the Head of Quality and this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

About you
We are seeking a highly motivated QC manager. You are independent, good at driving your own work forward and you have a good ability to take your own initiatives. You are a natural QC leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, you will need the ability to handle new situations with ease as well as many different issues simultaneously.

Qualifications:

  • You must have experience of management of GMP QC laboratory
  • You have documented knowledge of in process controls such as automated cell counting, cell viability measurements, media biomarker analysis, or image-based culture analysis tools
  • You are familiar with the analysis techniques; flow cytometry and qPCR, among others
  • Be able to speak / write Swedish and English fluently
  • You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)
  • Knowledge of microbiology
  • A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
  • You have at least 10 years of experience from the quality control within pharmaceutical industry
  • Extensive GMP knowledge and experience

Interested?
In this recruitment process, Procella Therapeutics is collaborating with Mpya Sci & Tech. Please submit your application no later than the 10th of October. Interviews will be scheduled on a continued basis. If you have any questions, please contact Emelie Gralberg, +467028886705, emelie.gralberg@mpyascitech.com.

About Procella Therapeutics
Based in Stockholm, Procella Therapeutics is an early stage biotechnology company focused on developing cardiac stem cell technology leveraging research from Harvard University and Karolinska Institutet with the aim of treating heart failure. Procella is collaborating with AstraZeneca to take our first cellular product candidate from pre-clinical stage to first-in-human studies and, if successful in early trials, further development towards commercial manufacture.

Equal Opportunity Work
At Procella we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

 

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