Arbetsbeskrivning

SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.

To our Regenerative Medicines segment, the business unit Procella Therapeutics AB, we are now seeking an experienced Senior QC Manager to join the growing QC team. 

About The Position

As Senior QC Manager you will be leading the GMP Quality Control laboratory together with a great team of highly competent colleagues, and you will be working at a patient-focused, growing and developing company that strives to unlock the full potential of cell-based advanced therapies for patients in need.

As a QC Manager, you will be leading a team consisting of three QC members and ensuring all QC activities are scheduled and executed. You will be allocating resources, setting budget, executing analytical technological transfers, ensuring instrument and equipment qualifications, drive development and management of SOPs, methods and their validation/verification while ensuring compliance at the outsourced CLOs. This role will work closely with cross functional teams internally (development, manufacturing, quality and CMC organizations) and reporting to the Head of Quality and Qualified Person. It is a full-time position located at SmartCella's Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities

• Leading Procella’s GMP Quality Control laboratory 
• Personnel management   
• Develop/approve among other SOPs, methods, specification, validation/qualification documentation, reports etc. 
• Ensure bioanalytical method validation/verification/qualification is performed according to cGMP
• Ensure purchasing of material/reagents/instruments, qualification and maintenance and calibration
• Support in validation (IQ/OQ/PQ) activities of equipment and instruments 
• QC member in various cross-functionally projects such as tech transfers
• Act as an expert and be an advisor regarding quality control issues/queries
• Ensure/Lead assay/method tech transfer activities from development laboratories/external CLO to Procella GMP QC laboratory  
• Be responsible for GMP compliance within your area and provide oversight of outsourced activities
• Responsible for communication with CLOs in analysis issues
• Perform method improvement work and trouble-shooting in collaboration with CLOs and development teams
• Responsible for developing and setting up new methods for analysis of (release, IPC) for starting material (Master Cell Bank, Working Cell Bank), Drug Product and Raw Materials as needed
• Participate/support in authority inspections

Qualifications

• You are a strong leader and must have previous 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 have a scientific background and are familiar with the analysis techniques; among other, flow cytometry, qPCR, ddPCR and ELISA.
• Be able to speak / write English fluently
• You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)
• 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

Personal attributes

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, with you handle new situations with ease as well as many different issues at the same time.

Equal Opportunity Work

At SmartCella we welcome, and value 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.

If you are interested in this unique opportunity, please submit your application (including cover letter) today. We will handle applications continuously. 

We look forward receiving your application!