Lediga jobb Procella Therapeutics AB 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 ambitious Validation leader to join the growing manufacturing team. If you are interested in this unique opportunity, please submit your application (including a cover letter).

About The Position

We are seeking a highly motivated individual with attention to details to join us as Validation leader. The validation leader will be part of the manufacturing development team and oversee the validation projects within the department. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference. As a Validation leader, you will be devising a validation organisation and be responsible for coordinating the validation activities for GMP manufacturing of ATMPs. This role will work closely with cross functional teams internally (development, manufacturing, QC, CMC and, regulatory). Reporting to the Head of Production, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities

- Developing and manage validation/qualification/verification life cycle procedure(s) for the company
- Ensure that validation/qualification/verification standard procedure(s) are compliance with GMP and other regulatory requirements
- Review/Issue validation documentation such as URS, IQ, OQ, PQ, risk assessments, VMP and reports
- Handling CAPA and initiation of deviation
- Support cross functional and external activities related to validation
- Issue SOP and training related to validation
- Implement a calibration and preventive maintenance program


Skills & Qualifications:

- Third level degree in a science/engineering/computer subject as a minimum.
- At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry.
- Good understanding and application of GMP and regulatory requirements.
- Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.


Qualifications

- You must have experience of working with Validation management (writing, reviewing, and approving related documentation), ideally within the pharmaceutical industry
- Be able to speak / write Swedish and English fluently
- You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)
- A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
- You have at least 5 years of experience from the pharmaceutical industry, preferably within biopharmaceuticals
- Extensive GMP knowledge and experience


Personal attributes

You are independent, good at driving your own work forward and you have a good ability to take your own initiatives. You are a natural leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.

Equal Opportunity Work

At Procella we welcome, and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs. Visa mindre

Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and is seeking a highly motivated individual to join our team. As a Laboratory Inventory and Logistics Coordinator, you will report directly to the Lab Manager and Head of the Development team. This full-time position is located at Procella Headquarters in Tullinge, greater Stockholm area.

Responsibilities:

- Support laboratory administrative and procurement system: Responsible for ordering, receiving, inspecting, labelling, storage, and distribution of all reagents, supplies and lab consumables
- Maintain the database of all laboratory inventory, materials, and supplies.
- Support the process of laboratory receiving/shipping: From requests and discussions with the lab team to documentation of confirmed delivery status.
- Ensure items are delivered to the correct people and are stored under the correct conditions.
- Work together with the lab management and lab operations to initiate, evaluate, and maintain service contracts for equipment.
- Manage equipment maintenance contract and keep records of all services in the electronic equipment maintenance database.
- Liaise with external contractors to coordinate the regular preventative maintenance of equipment ensuring that the required schedules are followed to maintain the equipment warranties and compliance
- Employ team-player approaches to ensure procedures of the laboratory are compliant with corporate and regulatory standards. Perform additional tasks as required: e.g. review SOPs.
- Support overseeing of all aspects of safety and compliance, including tracking/managing hazardous materials and laboratory safety inspections.
- Assume accountability for successful operations of development laboratories by implementing steps to improve efficiency, troubleshooting issues, and increasing the effectiveness of the lab over time.
- Assign consumables costs to suppliers and to specific activities in finance sheets. Liaise expenditure with finance and development management.


Qualifications and skills:

- Prior experience managing and working safely in a biological sciences/mammalian cell culture laboratory. Familiarity with a broad range of laboratory equipment used in cell culture laboratories.
- The work requires physical ability to lift weights (e.g., 10 kg boxes) and to use stairs daily.
- Ability to work in a highly cross-functional team environment.
- Ability to communicate timely and effectively with lab team and supervisor.
- Good organizational, time management and prioritization skills.
- Continuous improvement mindset that constantly seeks to improve work efficiency and safety.
- Experienced in MS Office tools MS Word and MS Excel.
- Excellent speaking and writing proficiency in English (Swedish is meriting).
- Good technical writing skills to support contributing to internal documentation. Visa mindre

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. Visa mindre

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 CMC to join its growing team. If you are interested in this unique opportunity, please submit your application (including a cover letter).?

About The Position
We are seeking a highly motivated individual to join us as Head of CMC. The Head of CMC will lead the development of the CMC strategy for our cell and gene therapy products and drive the development and execution of the CMC strategy with focus on all stages of product cycle. The individual will be accountable for developing and delivering the integrated CMC development plan while working closely with cross-functional teams internally (development, manufacturing, quality, regulatory) and with stakeholders to drive alignment and achievement of CMC development and manufacturing milestones in accordance with program timelines. In addition, the Head of CMC may also serve as project management interface between internal functions and external business partners. Reporting to the Chief Executive Officer, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities
Lead and represent the cross-functional CMC team with focus on early/mid/late-stage programs through global commercial license application and approval
Define and implement an integrated CMC Product Development strategy for the programs and drive alignment with functional leaders and other key stakeholders
Work across functions to ensure development and manufacturing activities are delivered in accordance with timelines and executed on time according to plan
Align CMC team members on content and strategy and create synergy in activities. This includes manufacturing campaigns, process/analytical development, functional characterization, release testing, tech. transfer, comparability campaigns, stability studies, regulatory filings, and other CMC-related activities.
Track, compile, review, and ensure timely delivery of documents in support of regulatory filings and responses. Ensure the proper scientific rigor to deliver successful clinical outcomes.
Work with heads of department to ensure appropriate resourcing and budget development by strategic assessment of milestones and corresponding resource requirements, while providing periodic review of forecasted expenditures. Regularly communicates cross functionally to assess and confirm appropriate allocation and utilization of resources.
Provide guidance and mentorship to the functional leads/subject matter experts within the CMC team. Maximize alignment, cooperation, input, decision making, commitment and synergy of CMC team members to ensure their technical contributions meet/exceed program objectives. Builds and motivates teams to become high performing.
Actively involve and support the initiatives to support Product Lifecycle business operations, such as streamline development strategies across early to late stage projects, and establish knowledge management system.


Qualifications
BS/MS or PhD in a scientific field with ?10 years of experience in biopharmaceutical development, preference in cell and/or gene therapy products.
Ability for critical thinking and innovation; highly motivated, willingness to acquire new skills.
Demonstrated successful cross-functional leadership track record and ability to work with tech ops teams to successfully drive results. Proficiency in strategic planning, cross-functional performance management, people dynamic management, and technical leadership.
In-depth technical understanding of early to late-stage clinical development of cell therapy products, including Process/Analytical Development, GMP Manufacturing CMC, and Regulatory.
In-depth experience with CMC Regulatory strategy to drive resolution of health authority questions or requests and the milestones and activities necessary to drive regulatory filing documentation.
Proven leadership experience and savvy influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team-building, communication, and organizational skills required.
Excellent written and verbal communication skills Visa mindre

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, 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 Scientist. The successful applicant will be responsible for the development of scaleable manufacturing processes of our first cell-based therapy product. The Process Development Scientist will report directly to the Senior Scientist of the Development team. 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.




Contact (application):
[email protected] 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 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).


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

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, 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 Scientist. The successful applicant will be responsible for the development of scaleable manufacturing processes of our first cell-based therapy product. The Process Development Scientist will report directly to the Senior Scientist of the Development team. 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.




Contact (application):
[email protected] 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

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. 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 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).


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