Senior Scientist Analytical Development, Flow Cytometry
2 weeks ago
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 crossfunctional 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.
- Ph.
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 multicolor 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 inprocess 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 designofexperiment 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 fastpaced 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.
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