Senior Scientist Analytical Development, Flow Cytometry

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.