Lediga jobb som Biomedicinare i Botkyrka

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 Head of Development (Process/Analytical) 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 Head of Development (Process/ Analytical). The Head of Development will be responsible for leading the process and assay development activities at Procella. This role will lead a team of Scientists to develop the process for a Phase 1 clinical study, perform process and assay characterization, and provide control strategies of process performance to ensure the process is efficient, on time, on budget and executed with high quality. Duties include managing and coaching staff from technical operations team (development), writing timelines and plans to move into Phase 1 studies, and developing annual budgets. Reporting to the Director of Development and CMC, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.


Job Responsibilities
Plans, directs and executes the development of processes and analytical assays for the manufacture of cell-therapy products in large scale in a GMP environment
Demonstrates a breadth of knowledge and skills to support the development, optimization, and management of protocols of high complexity to advance development of analytical methods and stem cell processes. Occasionally demonstrates subject matter expertise.
Plans, conducts and directs scientific work on extremely complex project necessitating the origination and application of new and unique approaches. Manage, monitor and control: safety, quality, costs and budgets.
Independently authors and approves technical documents, such as protocols, test methods, reports, certificates of analysis and operating procedures, with accuracy, thoroughness, and regulatory compliance
Leads the technical transfer of manufacturing processes and assays into GMP production
Represent the Process Development team both internally and externally
Identifies and independently drives department level improvements
Lead, motivate, and engage an energetic and innovative team of technical specialists. Continuously improve project execution.
Experience in Design of experiment statistical tools (e.g. JMP, DExpert, others)


Qualifications
PhD or Master’s Degree in biological engineering, chemical engineering, biological sciences or related field with 14+ years experience (8+ for PhD) in relevant industry experience
Cross-functional leadership capabilities with seasoned experience in people management, sub-functional oversight, and development
Strong communication skills, able to manage effectively multiple level communications up to management and down to project team members
Hands-on experience in mammalian cell culture, ideally differentiation and bioprocess manufacturing of pluripotent stem cells
Proven ability to structure, plan and execute in a fast-paced environment
Excellent organizational and problem solving skills, with demonstrated ability to extend these across a team implement efficient operational processes. Visa mindre

Research Associate Job Ad

Procella Therapeutics AB is a start-up biotech company on a mission to create stem cell-based therapy for heart disease and is seeking an outstanding Research Associate to join its growing multi-cultural team.


If you are interested in this unique opportunity, don't hesitate to submit your application as soon as possible (including a cover letter) to [email protected].


About The Position


This full-time support role will focus on the development of Procella’s current cell-based product to treat cardiac disease. In specific, the culture and differentiation of human pluripotent stem cells (PSCs) into cardiomyocytes, as well as related analytical assays. Key activities of Research Technician will include supporting daily activities of general lab management, expansion and differentiation of PSCs in adherent culture, cell purification, cell banking, and performing in-process controls and product characterization tests according to standardized analytical protocols. Reporting to Senior Scientist, the Research Associate will be responsible for the production and characterization of consistently high-quality differentiated cells using standard operating protocols and to contribute towards the goal of creating a cell therapy product.




Main Responsibilities


For this supportive role, the primary focus will be to reliably and consistently expand and differentiate human embryonic stem cells into cardiomyocytes in adherent culture and future upscaling. Key activities will include cell banking, stability studies and performing in-process controls according to standardized protocols.


Who are you?


Required Professional Qualifications
Master’s or Bachelor’s Degree in Biotechnology, Biomedical Engineering, Biomanufacturing or related field
Experience with cell culture with excellent sterile technique
Hands on experience with flow cytometry and/or qPCR
Demonstrated capabilities in planning and executing experiments
Ability to quantify experimental results and report to Senior Scientists and present to the team





Required Personal Qualifications
Good oral and written communications skills in English.
Excellent organizational skills, ability to manage multiple projects and carefully keep records.
Highly self-motivated with ability to perform well in a team setting
Able to troubleshoot and problem solving
Goal-oriented thinking and executing
Able to legally work in Sweden



Preferred Qualifications
Experience with human pluripotent stem cell culture
Experience with assay development
Hands on in adherent and suspension culture in automated bioreactors
Experience in animal cell bioprocessing (upstream and downstream)
Creativity and innovation
Industry experience in process/analytical development
Experience in a GMP manufacturing environment Visa mindre

Procella Therapeutics AB is a start-up biotech company on a mission to create stem cell-based therapy for heart disease and is seeking an outstanding Research Technician to join its growing multi-cultural team.


If you are interested in this unique opportunity, do not hesitate to submit your application (including a cover letter) as soon as possible.


About The Position


This full-time support role will focus on the development of Procella's cell-based product to treat cardiac disease. Specifically, the culture and differentiation of human pluripotent stem cells (PSCs) into cardiomyocytes, as well as related analytical assays. Key activities of Research Technician will include supporting daily activities of general lab management, expansion and differentiation of PSCs in adherent culture, cell banking and performing in-process controls and product characterization tests according to standardized protocols. Under the supervision of the Senior Scientists, the Research Technician will be responsible for the production and characterization of consistently high-quality differentiated cells using standard operating protocols and to contribute towards the goal of creating a cell therapy product.




Main Responsibilities


For this supportive role, the primary focus will be to reliably and consistently expand and differentiate human embryonic stem cells into cardiomyocytes in adherent culture and future upscaling. Key activities will include cell banking, stability studies and performing in-process controls according to standardized protocols.


Who are you?


Required Professional Qualifications
Master's or Bachelor's Degree in Biotechnology, Biomedical Engineering, Biomanufacturing or related field
Experience with cell culture with excellent sterile technique
Hands on experience with flow cytometry and / or qPCR
Demonstrated capabilities in planning and executing experiments
Ability to quantify experimental results and report to Senior Scientists and present to the team





Required Personal Qualifications
Good oral and written communications skills in English.
Excellent organizational skills, ability to manage multiple projects and carefully keep records.
Highly self-motivated with ability to perform well in a team setting
Able to troubleshoot and problem solving Visa mindre