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QC Manager within Protein Analysis, BioLamina, Sundbyberg

Are you experienced within QC for proteins? Would you like to manage all QC activities in a small biotech company going towards GMP? If you’d also like to work in an entrepreneurial company with local R&D and production, this might be the job for you! BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We are a growing team of 25 people working within production, R&D, quality and customer service.... Visa mer
Are you experienced within QC for proteins? Would you like to manage all QC activities in a small biotech company going towards GMP? If you’d also like to work in an entrepreneurial company with local R&D and production, this might be the job for you!


BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We are a growing team of 25 people working within production, R&D, quality and customer service. BioLamina produces and develops premium laminins, which are proteins used in e.g. stem-cell research. Our quality system is developing, and so the entire company, and we’re striving to work according to GMP.


Initially, you will be the only QC at the company. Your main task is to validate our quality control methods and execute them. You will also be responsible for developing and maintaining the documentation routines for the QC part of the system as well as for the planning of stability programs and executing stability studies. Reponsibilites include:


Run regular QC testing for release of recombinant protein products
Method development
Method validation
Plan, design, and perform stability studies
Issue specifications for cell banks and recombinant protein products
Support other departments in troubleshooting, investigations, improvement work, etc.
Manage suppliers of outsourced QC testing services



Since BioLamina is an entrepreneurial company, there will be great opportunities for you to shape, structure and implement QC routines. You will report to the Head of Quality.


Location:BioLamina in Sundbyberg.
Terms of employment: the position is open-ended with employment at BioLamina.
Start date:upon agreement




Qualification requirements:




Academic degree within Science (Chemistry, Pharmacology, Biology, Biotechnology or similar)
At least 5 years’ experience from the pharma industry, e.g. within QC, QA, Regulatory/CMC, development or similar
Several years of experience from working within QC
Strong skills in protein chemistry and analysis, especially HPLC
A profound understanding of GxP
Very good written and spoken English



Meriting qualifications:
Experience from cell bank development, characterization, and testing
Experience from outsorcing of QC analyses
Written and spoken Swedish



You need to be able to prioritize, plan and execute QC activities independently. At the same time, collaboration and communication with other departments and external suppliers are key skills.


Is this you? Welcome with your application!




Application & more information:


In this recruitment BioLamina is working with Search4S, Recruitment Consultant Anna Rennermalm. For more information contact Anna Rennermalm, +46 707 94 20 05 or [email protected].


Last application date: Dec 13th 2020


Interviews and selection of candidates will be continuous.




About Biolamina:?


BioLamina is a Swedish biotechnology company with a global presence. We offer an expansive portfolio of chemically defined and animal component-free laminin proteins for a variety of applications, including a reliable expansion of pluripotent cell and differentiation and maintenance of specialized cell types.


BioLamina’s Biolaminins™ are the only original full length, human, recombinant laminin cell culture substrates on the market and the impact of our Biolaminin matrices on cell culture quality has been scientifically validated in many high-impact journals.


The company was established in 2009 and was co-founded by Dr. Karl Tryggvason and his son Dr. Kristian Tryggvason. Today the company has about 25 employees spanning from production, R&D, logistics, sales, and marketing. We are a profitable company with an annual increase in revenue of approximately 50 %


www.biolamina.com Visa mindre

Head of Quality, BioLamina, Sundbyberg

Ansök    Okt 28    Search4S Dustgoat AB    Kvalitetschef
Do you know quality assurance for pharmaceutical products? Would you like to lead a quality team in building and maintaining quality processes and documents? If you’d also like to work in a small, entrepreneurial, research-oriented company with local production, this might be the job for you! BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We are a growing team of 25 people working within prod... Visa mer
Do you know quality assurance for pharmaceutical products? Would you like to lead a quality team in building and maintaining quality processes and documents? If you’d also like to work in a small, entrepreneurial, research-oriented company with local production, this might be the job for you!


BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We are a growing team of 25 people working within production, R&D, quality and customer service. BioLamina produces and develops premium laminins, which are proteins used in e.g. stem-cell research. Our quality system is developing and we’re striving to work according to GMP. As Head of quality, you will lead the way!


You will lead a small team within QA and QC. Your tasks and responsibilities include:
Staff responsibility
Responsibility for the Quality Management System
Issuing, reviewing and approving SOPs, deviations, CAPAs, Change Controls and customer complaints
Reviewing and approving specifications and study plans within development and stability
Release of products to market
Supporting other departments in trouble shooting, investigations and improvements, e.g. production, R&D and sales.
Participate in the management team and development of strategies.



Since BioLamina is an entrepreneurial company, there will be great opportunities for you to shape, structure and implement overall quality processes. All other functions at BioLamina are next door!


We created a website with more information about this position: https://search4s.teamtailor.com/pages/biolamina-head-of-q-and-production


Location:BioLamina in Sundbyberg.
Terms of employment: the position is open-ended with employment at BioLamina.
Start date:upon agreement




Qualification requirements:




Academic degree in a scientific subject (Chemistry, Pharmacology, Biology, Biotechnology or similar)
At least 5 years’ experience from quality assurance in the pharma industry or corresponding positions
Profound understanding of GxP, especially GMP
Very good skills in creating and reviewing SOPs, deviations, CAPAs, Change Control and/or customer complaints.
Very good written and spoken English



Meriting qualifications:
Experience from working with protein products is highly meriting
Experience from supplier evaluation
Experience from development projects
Good written and spoken Swedish
Previous leadership experience



As a person, you enjoy creating systems and work hands-on with quality documents as well as taking care of your staff and collaborating closely with other departments. You have the capacity to keep GMP in mind and the patience to implement improvements step by step.


Is this you? Welcome with your application!




Application & more information:
In this recruitment BioLamina is working with Search4S, Recruitment Consultant Anna Rennermalm. For more information contact Anna Rennermalm, +46 707 94 20 05 or [email protected].


Last application date: Nov 1st2020


Interviews and selection of candidates will be continuous.


About Biolamina:
BioLamina is a Swedish biotechnology company with a global presence. We offer an expansive portfolio of chemically defined and animal component-free laminin proteins for a variety of applications, including a reliable expansion of pluripotent cell and differentiation and maintenance of specialized cell types.


BioLamina’s Biolaminins™ are the only original full length, human, recombinant laminin cell culture substrates on the market and the impact of our Biolaminin matrices on cell culture quality has been scientifically validated in many high-impact journals.


The company was established in 2009 and was co-founded by Dr. Karl Tryggvason and his son Dr. Kristian Tryggvason, currently CEO. Today the company has about 25 employees spanning from production, R&D, logistics, sales, and marketing. We are a profitable company with an annual increase in revenue of approximately 50 %


www.biolamina.com Visa mindre

Head of Production, BioLamina, Sundbyberg

Are you an experienced leader within protein production according to GMP, ISO 13485 or corresponding standards? Would you like to lead our production team to improved processes and quality standards? As Head of Production at BioLamina you’d manage the production team within cell culture, protein purification and filling & labelling. BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We develop an... Visa mer
Are you an experienced leader within protein production according to GMP, ISO 13485 or corresponding standards? Would you like to lead our production team to improved processes and quality standards? As Head of Production at BioLamina you’d manage the production team within cell culture, protein purification and filling & labelling.


BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We develop and produce premium laminins, which are proteins used in e.g. stem-cell research. The laminins are produced in small-scale cell cultures of adherent and suspension cells followed by protein purification.


BioLamina has come far from the laboratory bench were we started and we are still developing. Today there are seven people working in the production and we are planning to expand. Major tasks will be to develop the independence & competence of the team, documentation and traceability as well as improvement of processes. You will also manage projects, eg in up-scaling, and take an active role in preparing production for GMP. As Head of Production you work closely to the production and the production team.


Your tasks and responsibilities include:
Staff responsibility including scheduling, salaries, budget & recruitments.
Development of the staff, including delegating tasks and areas of responsibility ad follow up results.
Responsibility for meeting production goals according to quality standards
Develop and implement traceability and documentation, striving towards GMP, in close collaboration with the Quality department.
Lead & implement process improvement projects and track key performance indicators.
Participate in the management team and development of strategies.



Since BioLamina is an entrepreneurial company, there will be great opportunities for you to shape and improve the production. This is a key position for BioLamina’s future. You will work closely with QA, QC, R&D and Sales. At BioLamina we are all next door!


We created a website with more information about this position: https://search4s.teamtailor.com/pages/biolamina-head-of-q-and-production


Location:BioLamina in Sundbyberg.
Terms of employment: the position is open-ended with employment at BioLamina.
Start date:upon agreement




Qualification requirements:


This is a position that requires strong leadership skills and a readiness to participate in an evolving company culture. You should be prepared to introduce technical and cultural changes, as we are moving towards improved ways of working. You need to be very good at prioritizing, delegating, following up and supporting your staff in daily production and projects. There is a need for a structured and communicative leader with a can-do-attitude. You understand that changes take time and that everyone needs to be on-board.


Requirements:


Academic degree within engineering, biology, chemistry or corresponding work-life experience.
Several years of experience from managing a team within production of proteins or similar products.
Very good understanding of production according to high quality standards, e.g. GMP, ISO 13 485 or similar.
Very good knowledge of cell culture or protein purification.
Experience from process improvement projects, upscaling and/or tech transfer
Very good written and spoken English



Meriting qualifications:
Experience from working with both adherent and suspension cell cultures
Experience from building and implementing processes according to GMP or ISO 13 485
Good written and spoken Swedish





Is this you? Welcome with your application!




Application & more information:
In this recruitment BioLamina is working with Search4S, Recruitment Consultant Anna Rennermalm. For more information contact Anna Rennermalm, +46 707 94 20 05 or [email protected].


Last application date: Nov 1 2020


Interviews and selection of candidates will be continuous.








About Biolamina:
BioLamina is a Swedish biotechnology company with a global presence. We offer an expansive portfolio of chemically defined and animal component-free laminin proteins for a variety of applications, including a reliable expansion of pluripotent cell and differentiation and maintenance of specialized cell types.


BioLamina’s Biolaminins™ are the only original full length, human, recombinant laminin cell culture substrates on the market and the impact of our Biolaminin matrices on cell culture quality has been scientifically validated in many high-impact journals.


The company was established in 2009 and was co-founded by Dr. Karl Tryggvason and his son Dr. Kristian Tryggvason, currently CEO. Today the company has about 20 employees spanning from production, R&D, logistics, sales, and marketing. We are a profitable company with an annual increase in revenue of approximately 50 %


www.biolamina.com Visa mindre