Senior Scientist - Bioprocess Development

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 Bioprocess 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 Bioprocess Development-Senior Scientist. The successful applicant will be responsible for the development of scaleable manufacturing processes of our first cell-based therapy product. The Bioprocess Development Scientist will report directly to a Senior Scientist of the Process Development team. This full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.


Key Accountabilities:
Plan and costing of process development experimental plans with defined deliverables, milestones, and timelines to support achievement of corporate milestones
Development of a scalable, robust, high yielding, and economically viable cell culture processes using small-scale, bench-scale, and larger disposable up-/down-stream technologies in the laboratory setting.
Generate, manage and evaluate critical data (statistical analysis incl. DoE), support the writing of technical reports of process development operations as need.
Line management of direct reports
Work closely with development team members to design, execute, and document process development activities
Responsible for executing agreed research independently with minimal supervision
Independently analyse raw data to a high standard and present results to project teams and external clients/collaborators as appropriate
Prepare accurate and technically cohesive analytical reports and present internally and externally as appropriate
Maintain accurate records and manage raw data in line with company policies
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


Key responsibilities:
To be responsible for the quality of the process development work carried out under assigned projects, this will be achieved by:
Managing and execute the work assigned to their projects.
Develop scalable and efficient upstream processes of expansion and differentiation of pluripotent stem cells, using single use processing technologies (e.g. bioreactors for cell culture in adherent and suspension culture, and peripheral systems)
Develop downstream processes for wash, purification, formulation, vialing and freezing using single use processing technologies (e.g. tangential filtration, fludized bed-centrifugation, magnetic activated cell sorting, others)
Responsible for executing agreed research independently with minimal supervision
Produce detailed protocols and documentation to support transfer of processes 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 process 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 R&D laboratories as required.
Support laboratory management activities and contribute to housekeeping and safety within the laboratory.


Skills/Competencies requirements:
Hands on experience with mammalian cell culture, aseptic techniques (experience in culture-expansion and differentiation of pluripotent stem cells is highly favourable, as well as experience in cell and gene therapy sector).
Proven experience and expertise in bioprocess development and scaling. Hands-on in single-use cell processing technologies to scale up upstream and downstream development.
Experience in cell-based analytical assays is required (flow-cytometry, qPCR, are desired).
Experience in using design-of-experiment methodologies for process optimisation is desirable (e.g. JUMP, DesignExpert).
Ability to manage and work effectively in a team. Be a team player.
Excellent organizational, interpersonal, and problem-solving skills.
Comfortable in a fast-paced small company environment with minimal direction 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.
Engineering experience in mechanical design or device development would be advantageous.
Excellent IT skills in MS Excel and other MS office tools (Word, PowerPoint)
Excellent written and oral communication in English.



Education:
PhD preferably in Biochemical Engineering, Chemical Engineering, Biotechnology or related field with 2 years of relevant industry experience (preferable).
Bs in Biological sciences with knowledge in process and analytical development with 5+ years of experience in a related industry environment.