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Referenznummer
(Datum/Uhrzeit):


10000-1157339163-S
(2017-10-26 17:49:19)

Kurzbeschreibung:


Senior Product Development Engineer (m/f) | Pharmazie ()

Einsatzort:


Berlin

Stellenbeschreibung:


Our client Mucos is an international company with a long tradition and look back on a successful company history. The company is a leader in the manufacture of enzyme-containing drugs and food supplements. The product Wobenzym is sold worldwide, mainly on the European market. The company is an important part of Atrium Innovations Inc. Mucos would like to grow together and place their product Wobenzym in other countries and markets. Mucos would like to help people transform their lives and get as healthy as possible. If you are a committed teamplayer with the urge to continuously change and improve something, then you will feel exactly in the right place within Mucos. Join us so we can both become even more successful and become a part of a great team. As part of the organizational development, we are currently looking for a: Senior Product Development Engineer (m/f) Location: Berlin Your tasks ?Define and implement product development strategy in accordance with market inputs ?Lead, execute and support product development projects, while establishing solid project planning, execution and monitoring ?Develop and optimize formulations of pharmaceutical dosage forms, primarily solid oral dosage forms, for new and existing products ?Evaluate and implement new active pharmaceutical ingredients and excipients and develop primary packaging material ?Develop formulations and materials for clinical studies ?Coordinate and execute all product-related qualification testing and performance studies in accordance with applicable standards and regulations ?Create and review product-related documentation ?Be the central know-how owner for all products ?Identify, qualify and manage pharmaceutical development partners ?Optimize product performance and reliability, using tools like Design Of Experiments, Risk Analysis, FMEA and applicable statistical methodologies ?Review, coordinate and execute deviations, corrective actions / preventive actions and change controls from a product development point-of-view ?Represent product development in the European Steering Committee, interacting with the commercial, regulatory and clinical functions ?Drive and improve alignment with the on-site enabling functions, like Process Engineering, Quality and Planning; demonstrate proactive cooperation and optimize communication structures Your profile ?5 to 7 years of experience in the development of pharmaceutical solid oral dosage forms and related ingredients, excipients and packaging ?Master degree in Pharmacy or comparable natural sciences ?Proven track record of successfully implementing game-changing product developments and ?improvements ?Strong project leadership skills: exceeding requirements and delivering on time ?Solid expertise with product performance qualification and all related validation elements in a cGMP pharmaceutical environment ?Strong capabilities in applying methodologies like Design Of Experiments, Risk Analysis and FMEA ?Technical know-how of manufacturing- and laboratory processes for solid oral dosage forms pharmaceuticals ?Well-founded know-how of applicable pharmaceutical regulations, licensing and electronic Common Technical Documents ?Demonstrated successes in operating in a multidisciplinary setting with regulatory affairs, medical affairs and clinical affairs ?Sincere interest in becoming the self-managing "owner" of all product development related aspects ?Strong documenting-, reporting- and presenting skills ?Fluency in English and German (oral and writing) ?Advanced expertise with MS Office and other software applications Desired characteristics ?Initial experience in a pharmaceutical production department ?Multi-company, international working experience ?Fluency in English and German (oral and writing) ?International business- or study assignments Please send your application including your notice period and your salary expectations to Karriere@limbourg.eu or apply directly through our website: www.limbourg.eu

Kontakt:


Limbourg & Associates Deutschland GmbH
Herr Thomas Glatzel
Königsallee 14
40212 Düsseldorf


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