Työnimike: CMC Project Manager

Työnkuvaus:
Do you have the passion, ambition and dedication to create new life-saving treatments for patients at need? Want to experience a vibrant, open-minded and motivating biotech? -That is us: Aurealis Pharma. Embracing Science. Enhancing Lives. We are expanding and have an exciting opportunity for a high caliber individual to join our team as a CMC Project Manager - Live Biotherapeutic Products (LBP). You will be responsible for the planning, co-ordination and reporting of GMP/CMC projects of a LBP to a team comprising of Company CSO and two Research Director's. KEY DUTIES AND RESPONSIBILITIES: 1.Act as Project Manager liaising with internal team and external service providers to ensure that the conduct and reporting of the project complies with the requirements of GMP, the Project Plan and relevant SOPs and is delivered on time. Ensure that appropriate level of communication is maintained internally and with service providers and that status and progress reporting meet requirements. 2.Ensure that all CMC projects under your management meet current and prospective global regulatory compliance, industry guidelines and internationally recognized quality standards. 3.Contribute to meetings with service providers, regulatory bodies and client companies when they visit the Company or we visit them. ROLE REQUIREMENTS: 1.Relevant degree in a Life Sciences related discipline as well as significant experience working within a GMP/CMC biopharmaceutical/LBP development environment, ideally in a LBP Company, Biopharmaceutical Company, or a Biologics CRO. 2.You will be expected to have an excellent understanding of the CMC development and commercial life cycle for biologics/LBP, including broad knowledge of analytical strategies and technologies for biologics. 3.A thorough understanding of GMP regulations and other applicable guidelines. 4.Confident with project management tools and software. 5.Excellent communication and organizational skills. 6.Ability to be an active team player and also work independently in a small Biotech environment Aurealis Pharma is a Basel Switzerland and Kuopio Finland based privately-held biopharmaceutical company focusing on developing broadly applicable proprietary technology to effectively, safely and economically modulate and re-educate the distorted host immune microenvironment to proper state in chronic inflammation and cancer. Company's technology is based on safe food-grade lactic acid bacteria delivering multiple human therapeutic proteins in target tissue to address the unmet medical need in chronic wounds and cancer.

Työnantajan nimi: Aurealis Ltd

Työnantajan osoite: Microkatu 1, 70210 KUOPIO

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Työn lyhyt kuvaus: Systeemisuunnittelijat

Maa: Suomi

Alue: Pohjois-Savo

Sopimuksen kesto: Tilapäinen

Sopimuslaji: Kokopäiväinen

Kokea: Yli 5 vuotta

Lähde työtarjous:
MOL/Työ- ja elinkeinoministeriö, Julkiset työvoimapalvelut, Suomi