Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and is seeking an outstanding Analytical Development Senior Scientist to join its growing team.
If you are interested in this unique opportunity, please submit your application (including a cover letter if possible).
About The Position
We are seeking a highly motivated individual to join us as a Senior Scientist Analytical Development. The successful applicant will be responsible for the development of analytical assays and suites supporting the monitoring and control of manufacturing processes and for the release and characterisation testing of our first cell-based therapy product. The Analytical Development Senior Scientist will report directly to the Director of Development. This full-time position is located at Procella AB Headquarters in Tullinge, Greater Stockholm Area.
- Plan and costing of analytical development experimental plans with defined deliverables, milestones and timelines to support achievement of corporate milestones
- Development of cell phenotype (Flow cytometry) and gene expression assays (PCR)
- Line management of direct reports
- Working closely with development team members to design, execute and document analytical development activities
- Responsible for executing agreed research independently with minimal supervision
- Ability to independently analyse raw data to a high standard and present results to project teams and external clients/collaborators as appropriate
- Ability to prepare accurate and technically cohesive analytical reports and present internally and externally as appropriate
- Ability to maintain accurate records and manage raw data in line with company policies
- Ability to produce detailed protocols and SOP’s to allow assay transfer both internally and externally
- Propose new ideas for modifications to assays or equipment to improve analytics.
- Managing the research carried out by the analytical development team assigned to the projects.
- Deliver detailed protocols and documentation to support transfer of assays to internal manufacture development and/or external clients.
- Ensuring the accurate recording, review and storage of laboratory generated data including sign-off for laboratory notebooks in line with Procella’s quality standards
- Disseminate analytical development work internally and externally where appropriate.
- Production of SOP’s and protocols to corporate quality standards as required.
- Act as “super user” for appropriate equipment and provide training to other staff members from the Development laboratories as required.
- Support laboratory management activities and contribute to housekeeping and safety according to corporate standards.
- Proven experience and expertise in assay development and automation. Hands-on in multiple cell-based analytical techniques and methods is required (e.g. flow-cytometry, qPCR, chemometrics, others). Proven experience in assay development, qualification and validation using the methods of flow cytometry and PCR.
- Hands on experience with mammalian cell culture, aseptic techniques (experience in culture of pluripotent stem cells is highly favourable). Experience in characterisation of human pluripotent stem cells and derivates is highly favourable.
- Experience in using design-of-experiment methodologies for process optimisation is desirable (e.g. JUMP, DesignExpert).
- Ability to manage and work effectively within a team. Be a team player.
- Excellent organizational, interpersonal, and problem-solving skills.
- Comfortable and resilient in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Ability to work quickly and accurately with a strong focus on detail, takes initiative when required.
- Knowledge of ICH Guidelines for analytical assays is strongly desirable (ICH Q2 R1). Awareness of Quality Assurance and Good Manufacturing Practices is a plus.
- Excellent IT skills in MS Excel and other MS office tools (Word, PowerPoint)
- Experience in scientific writing, keeps up to date with professional knowledge, expertise and best practice.
- Experience in bioinformatics is desirable.
- Excellent written and oral communication in English.
- PhD in Biochemistry, Biotechnology, Biology or related field with knowledge in analytical development with 5+ years of experience in an industry-related environment.
- MSc with 8+ years industrial experience within an appropriate Life Science environment that included working with cell and gene therapies.