At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

We are seeking a highly motivated Analytical Development Senior Scientistfor our team with a focus on CMC.

The Analytical Development Senior Scientist will innovate, design, develop, and implement flow cytometry based methods to support our pipeline of stem cell-based based advanced therapies. The successful candidate will need to independently design and perform experiments, analyze, interpret and troubleshoot results, and communicate/ present findings in meetings. The successful candidate will also need to manage a team of scientists and research associate technicians, collaborate across functional groups internally and externally. This position is ideal for an individual who is driven and passionate about cell therapy in a fast-paced one-team collaborative environment.

Key Role Responsibilities

• Design and develop robust analytical assays for characterizing cell - based drug substance and drug products using flow cytometers and/or other immunoassays.
• Author, review/approveassay development and qualification reports with solid datasets to evaluate assay characteristics are suitable for qualification and validation.
• Perform analytical assays to provide insights for process and product.
• Drive assay life cycle, including assay optimization, transfer, and qualification.
• Work with Tech Operations cross-functional teams to draft study protocols, and technical reports.
• Author and review relevant CMC sections for regulatory submissions.
• Lead projects to deliver objectives timely and within budget
• Represent the analyical development team as SME,effectively communicate progress or issues in team meetings and prepare data and deliver presentations internally and externally.
• Perform routine assays for drug product release and characterization
• Coordinate tasks across functions, demonstrating prioritization and planning
• Present work to key stakeholders and leadership
• Line manage direct reports, mentor team members and grow the team within corporate core values.

Preferred Qualifications

• Ph.D. in cell and/or molecular biology, biochemistry, biotechnology or another relevant field with at least 7+ years of relevant experience in flow cytometry and analytical method development.
• Proven experience in cell therapy and flow cytometry and different cytometers, designing and running multi-color panels (+10 colors) and data analysis softwares.
• Theoretical understanding of stem cell biology around novel targets and pathways and/or proteomics to drive scientific testing, product release/charaterisation and in-process monitoring of manufacturing processes.
• Hands on experience with mammalian cell culture, aseptic techniques (experience in culture of pluripotent stem cells is highly favourable).
• Experience in using design-of-experiment methodologies for process optimisation is highly desirable (e.g. JUMP, DesignExpert).
• Working knowledge of GLP requirements and international standards pertaining to method qualification, validation, and stability. Knowledge of GMP is desired.
• Experience managing, mentoring and engaging direct reports is desirable.
• Mindset for innovation and automation.
• Ability to manage and work effectively within a team. Be a team player.
• Excellent interpersonal, verbal and written communication skills.
• Comfortable in a flexible and fast-paced company.
• English of excellent level, Swedish is a merit

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

SmartCella is a world-leading biotech & medtech 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 60 employees from more than 20 nationalities.