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, Procella Therapeutics AB, we are now seeking an experienced as QA Specialist – Microbiological Quality Assurance.

About The Position 

This is a role for someone who is ready to work in a QA role with many internal and external contacts. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference. As a QA Specialist – Microbiological Quality Assurance, you will provide QA oversight towards GMP clean rooms (grade D - Grade A), while ensuring cGMP of internal manufactured products. This role will work closely with cross functional teams internally (development, manufacturing, QC). Reporting to the Head of Quality and Qualified Person, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities

• Provide Quality oversight for environmental monitoring of manufacturing facility and cleaning verifications 
• QA representative in validation activities (CV) of facilities, equipment/instruments, material transfer and certification activities (gowning)
• Ensure facility and quality systems state of compliance with internal requirements and appropriate regulations 
• Lead/Participate in developing action plans to correct deficiencies to ensure the adequate microbiological quality of the site facilities, utilities, processes, and products
• Analyze and interpret environmental monitoring data, identify trends, and implement adequate corrective actions
• QA lead in design and development of Aseptic Process Simulations / Media Fills
• Handle various documentation revisions (including SOPs etc.)
  
• QA member in various cross-functionally teams and projects (tech transfers) to ensure microbial contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes
• Act as an expert and be an advisor regarding GMP in quality issues from a environmental view
• Develop and deliver training programs to facility staff on contamination prevention and control, Cleanroom behavior, microbial theory and hygiene best practices
• Be responsible for GMP compliance within your area
• Responsible QA for potential deviations, risk assessments and change controls within own area
• Lead and guide Investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures.
• Handle GMP quality related issues both internally and externally with Procella’s GMP suppliers
• Support/Participate in audits and regulatory inspections Pharmaceutical Microbiology subject matter expert
  
• Quality oversight of CLOs 

Qualifications

• A high-level education (university degree or similar) within relevant area (preferably in microbiology)
• GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience
• Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA)
• Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbiological control strategy required
  
• You must have experience of working with GMP environmental monitoring / microbial laboratory
• Be able to speak / write Swedish and English fluently

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 QA 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 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.

If you are interested in this unique opportunity, please submit your application (including a cover letter) today. We will review applications on an ongoing basis and hope to fill the position as soon as possible.

 The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities.