Scientist-Analytical Development

Analytical Development Scientist

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, don't hesitate to submit your application (including a cover letter).


About The Position
We are seeking a highly motivated individual to join us as an Analytical Development Scientist. The successful candidate will play a central role in setting up and maintaining an innovative analytical capability which will support the development of analytical assays for the release and characterisation of starting cell materials, In-Process monitoring and control of scaleable manufacturing, and the release and characterisation of our first cell-based therapy product. The Analytical Development Scientist will report directly to the Senior Scientist of the Analytical Development group. This full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.


Key Accountabilities:
· 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.


Key responsibilities:
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.


Skills/Competencies requirements:
Hands on experience with mammalian cell culture, aseptic techniques (experience in culture of pluripotent stem cells is highly favourable).
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). 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.




Education:
PhD in Biochemistry, Biotechnology, Biology or related field with knowledge in analytical development with 2+ years of experience in an industry-related environment.
MSc with 3+ years industrial experience within an appropriate Life Science environment that included working with cell and gene therapies.