QC Manager within Protein Analysis
Biolamina AB / Kemiingenjörsjobb / Sundbyberg
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Solna,
Stockholm eller i
hela Sverige Are you experienced within QC for proteins? Would you like to manage QC activities in a small biotech company rapidly growing 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 41 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 within a few years. The company has a certified quality system according to ISO 9001:2015.
You will be strengthening our QC department as our second QC manager. Your main task is to perform quality control testing from our production process. 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. Responsibilities include:
Run regular QC testing for release of recombinant protein products
Review and approval of QC records
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
A profound understanding of GxP
Very good written and spoken English
Meriting qualifications:
Experience from cell bank development, characterization, and testing
Experience from outsourcing 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!
We will have an ongoing selection process so please send in your application as soon as possible. If you have any questions about the position,
please contact Head of Quality Harald Eriksson at
harald.eriksson@biolamina.comPubliceringsdatum2022-03-09Så ansöker duSista dag att ansöka är 2022-03-31
AdressBiolamina AB
Löfströms allé 5A
17266 Stockholm
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "Quality Control Manager".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Biolamina AB (org.nr 556764-1872)
Löfströms allé 5A (
visa karta)
172 66 STOCKHOLM
Ansökan E-post:
career@biolamina.com Jobbnummer 6419220
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