Do you know late-stage drug development?
Search4S Dustgoat AB / Apotekarjobb / Stockholm
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hela Sverige Would you like to take a vaccine through the regulatory process to the market? Have you worked with regulatory, CMC and / or quality within development, manufacturing or life cycle management of pharmaceuticals?
Intervacc is a Swedish biotech company dedicated to developing veterinary vaccines. Strangvac, a vaccine to prevent strangles, a streptococcal infection affecting horses, is currently in the end of clinical trials. As Intervacc is now almost ready to register their first product developed from scratch, the team is expanding.
At Intervacc, you will be a key member of a small team and will have a big impact. Together you will do what is needed for the projects to progress. Tasks include, but are not limited to:
• Reviewing, compiling and writing documentation regarding eg. quality, CMC, patient information and other regulatory information required for a Market Authorization Application.
• Act as a contact with external contacts, such as manufacturers, academic collaborations and consultants.
• Plan and evaluate stability studies
• Keep updated on relevant guidelines, e.g. VICH.
Intervacc is at a very dynamic stage in it development and the position will evolve over time, both to life cycle management but also early discovery projects. If you are looking for a scientifically interesting job with lots of opportunities, this is it!
Location: Hägersten, Stockholm, Sweden
Starting time: As soon as possible or upon agreement
Terms: The position is open-ended, full-time, with Intervacc as employer.
Qualification Requirements:
• Academic degree within e.g. science, pharmacology, veterinary medicine or engineering
• Understanding of regulatory guidelines, e.g. pharmacopoeias or ICH.
• Good understanding of biochemistry, e.g. protein chemistry
• Knowledge about method development and statistical analysis of immunological methods and chromatography
• Industrial experience from a pharmaceutical company within e.g. biological production, regulatory affairs, and/or quality assurance
• Very good written and spoken English
Meriting qualifications:
• Experience from working within or interacting with contract manufacturer
• Experience from working with quality systems.
• Knowledge about microbiology, both in production and in general
• PhD within a relevant field
• Good written and spoken Swedish
• Good written and spoken Spanish
As a person, you need to be proactive and take responsibility for both projects and communication with external partners. You are able to plan and execute your work independently in a structured manner.
Interrvacc is a Swedish company active in the biotechnology sector. We develop new vaccines based on recombinant proteins to meet the increasing need for effective animal health. The market for animal vaccines is growing globally, and our next generation vaccine technology and sales platform gives us great opportunities to take new market shares.
Together with our subsidiaries Nordvacc Pharmaceuticals and Mybac-Vettech Laboratory, we aim to strengthen animal health and well-being. Through its subsidiary Nordvacc, Intervacc has its own sales organization for over 30 years and so far sold more than 200 million doses of vaccine on the European Animal Health Market.
Intervacc is now after many years of research, at the final stage of the development of the Strangvac® vaccine against the highly contagious disease strangles in horses caused by Streptococcus equi. Today there is no safe and effective vaccine against strangles on the market.
www.intervacc.com.Varaktighet, arbetstid
This is an open-ended employment with Intervacc. It is not a consultant position.
Publiceringsdatum2018-10-26Så ansöker duSista dag att ansöka är 2018-11-23
Klicka på denna länk för att göra din ansökanKontaktAnna Rennermalm
anna@search4s.seFöretagSearch4S Dustgoat AB
AdressSearch4S Dustgoat AB
Västertorpsvägen 135
12944 Hägersten
KontorsadressVästertorpsvägen 135
Jobbnummer 4425578
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