Lediga jobb som Civilingenjör, bioteknik i Botkyrka

Do you want to use your skills within validation at an exciting company within specialised treatment? 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.

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. 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.

You will ensure that the validation and qualification SOP’s follow cGMP and other regulatory requirement. You will also issue/revise validation documentation such as URS, IQ, OQ, PQ, risk assessments, VMP and be responsible for the validation/qualification reports, and issue deviations, CAPA’s and CC’s when required. You will also implement a calibration and preventive maintenance program. 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.

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
• Be able to speak / write Swedish and English fluently
• You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)

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, you will need the ability to handle new situations with ease as well as many different issues at the same time.

Interested?

In this recruitment process, Procella Therapeutics is collaborating with Mpya Sci & Tech.

Please submit your application no later than the 10th of October. Interviews will be scheduled continuously. Questions? Please contact Linnéa Andersson, +4670 888 65 77 or [email protected].

About Procella Therapeutics

Based in Stockholm, Procella Therapeutics is an early stage biotechnology company focused on developing cardiac stem cell technology leveraging research from Harvard University and Karolinska Institutet with the aim of treating heart failure. Procella is collaborating with AstraZeneca to take our first cellular product candidate from pre-clinical stage to first-in-human studies and, if successful in early trials, further development towards commercial manufacture.

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

We are seeking a highly motivated individual to join us as an 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.

Key Accountabilities:
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.


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:
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.


Education:
PhD in Biochemistry, Biotechnology, Biology or related field with knowledge in analytical development with 5+ years of experience in an industry-related environment. Visa mindre

About DeLaval
DeLaval is the world-leader in development, manufacturing and providing dairy farming solutions. These solutions range from premium robotic milking and dairy farm management systems to advanced vision solutions, sensors and cutting-edge digital services based on pioneering machine learning algorithms, edge devices and cloud platforms. Our vision is to make sustainable food production possible. As a company built on innovation, we constantly work to find and innovate ways of creating value for our customers, dairy farmers; by developing world-leading milking equipment and solutions.
Today, DeLaval has approximately 4,500 passionate professionals operating in more than 100 markets around the world. DeLaval is part of the Tetra Laval Group. See more at www.delavalcorporate.com.
Technical Innovation Specialist
Do you have a passion for innovation and product development? Do you want to work in a high-tech company where you can contribute to a more sustainable world? DeLaval is strengthening its innovation capabilities by expanding the already successful Technical Innovation Team.
The team,
Technical Innovation (TI) team is part of DeLaval’s product development and management (PMD) organisation supporting DeLaval in its innovation journey. The team is a group of highly competent technical experts. We combine our technical know-how and deep dairy industry knowledge to identify, develop and proof new innovative technologies and new business opportunities that contribute to DeLaval’s product plan. We monitor dairy market needs, technologies developed by industry authorities or start-ups as well as academically developed solutions. For selected technologies and with the help of product managers and other colleagues at DeLaval’s product development (PD), we investigate these solutions from technical, business or IP point of view often through agreements and collaborations.
Key Responsibilities
DeLaval is currently making a major investment in innovation and digitization that is taken place in different parts of the organization. This includes expanding the technical innovation team with talented engineers who wants to be a part of their future innovation journey.
As a Technical Innovation Specialist, you are the cohesive link for innovation and innovation projects. Together with your colleagues in the team you act as the hub for explorative innovation within DeLaval where you support customer and innovation strategy by running proof of concepts initiatives, making technical assessments, managing technical partnerships, and exploring new technologies. The responsibility also includes to support the efficient transfer of concepts to product line organization for commercialization.
The role also includes:
Evaluate ideas and suggestions from external parties
Lead concept development projects and studies
Participate in developing the roadmap within innovation
Prepare project proposals and participates in projects funded by DeLaval’s Innovation Committee
Independently plan and run your own Proof of Concept projects
Run experiments in the test farm and lab

The role works cross functional and have a close dialogue with the product and engineering organization. Furthermore, you will support other functions that work with innovation within DeLaval. The position is located in Tumba, Ability to travel globally is a wish. Position reports to Manager Technical Innovation which is part of Product Management and Development (PMD).
Who you are
We are looking for a person with:
Data analytics skills and expert in machine learning.
Academic degree in engineering or veterinary & animal science, PhD preferred.
Must have knowledge or experimental background in dairy farming industry.
At least five years of experience working within research or product development environment.
Fluent in English or/and Swedish in both written and spoken.
Administrative skills (running concept projects, creating reports and presentations)

As a person you are:
Analytical
Open minded and innovative
A team player for whom communication and outreaching is never a challenge.

In this recruitment, your personal attributes will be of great importance. We are looking for a person who has a passion and great interest in innovation within product development, with a track record of creating results. To fit in with the team, you are a curious team player with an ability to find innovative and smart solutions. You are a communicative person who enjoys working cross-functional with many contact areas and you like to contribute with your experience and skills to others.
At DeLaval we believe diversity in our teams makes us develop better products as well as having the best working environment
What we offer,
As an employee of DeLaval you will get the opportunity to work in a beautiful but also practical environment, since the factory, development and the lab is adjacent to each other in Tumba south of Stockholm.
We offer you a workplace like no other, where state of the art technology go hand in hand with sustainable food production and animal welfare:
Market-based salary with an individual incentive program based on performance and company result.
A secure employment and benefits from the collective agreement (occupational pension, work-related accident insurance, parental leave, reduction of working hours)
Parental leave compensation (approx. 10 percent of the employee's monthly salary)
Wellness contribution of 2000 SEK/year
Private health insurance
Flexible working hours and a global remote working policy that allows employees to work from home in agreement with their manager
30 days paid vacation


Last day to apply is 6th of July 2022.
Do you want to know more?
Search: Innovation, Product development, Engineer, R&D, Research and Development, Data Analytics. Visa mindre

Bioprocess Development Scientist Job Ad

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 Process Development 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 a Process 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 of Technical Operations function. This full-time position is located at Procella Headquarters in Tullinge, Great Stockholm Area.


Key Accountabilities:
To work closely with the Technicians, Scientists, and Senior Scientists to ensure the successful delivery of project outputs to schedule and budget. With accountability for:
Develop scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable up-/down-stream technologies in the laboratory setting.
Generate, manage and evaluate critical data, support the writing of technical reports of process development operations as need.
Support analytical evaluation, interpret data and work with other team members to integrate results into overall process development plans.
Propose new ideas for modifications to processes or equipment to deliver improvements.



Key responsibilities:
To be responsible for the quality of the process development science carried out under assigned projects, this will be achieved by:
Managing the research carried out by the process development scientists assigned to their projects.
Produce detailed protocols and documentation to support transfer of processes to internal manufacture development and/or external clients.
Responsible for executing agreed research independently with minimal supervision
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.


Laboratory responsibilities:
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 of pluripotent stem cells is highly favourable).
Proven experience and expertise in bioprocess development and scaling. Hands-on in single-use cell processing technologies for 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. software tools 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.
· Knowledge of Quality Control and Quality Assurance issues is desirable.
· 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.
· Excellent written and oral communication in English.




Education:
Bs in Biological sciences with knowledge in process and analytical development with 5+ years of experience in a related industry environment.
PhD preferably in Biochemical Engineering, Chemical Engineering, Biotechnology or related field with 2 years of relevant industry experience (not mandatory). Visa mindre

Analytical Development Senior 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 an 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.

Key Accountabilities:
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.


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:
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.


Education:
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.


Contact (application):
[email protected] 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