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Pharmaceutical Specialist Copenhagen Denmark,  

Posted on : 18 May 2017

Project Description

Pharmaceutical Specialist Location Region Hovedstaden City Copenhagen Department Research and Development Application deadline 05 June 2017 Description We are currently looking for an experienced Pharmaceutical Specialist for a new position in Pharmaceutical Development & Manufacturing that will provide technical and strategic leadership for pharmaceutical development activities in support of our biologics pipeline (mAbs), spanning pre-IND stage through validation and launch. The department is part of Chemical and Pharmaceutical Research (CMC development) located in Valby. Our focus in CPR is to support the development of new drug candidates within depression, schizophrenia, Parkinson s disease and Alzheimer s disease. We strive to develop new innovating treatments to help improve the lives of the patients suffering from these diseases.In Pharmaceutical Development & Manufacturing we are 17 highly skilled and passionate colleagues who are focused on pharmaceutical development of all clinical and commercial formulations from early phase development to commercial implementation and life cycle management. The department works with both small molecules and biologics.Your job and key responsibilities You will be responsible for development of pharmaceutical formulations and processes to support our global development projects, with primary focus on the biologics projects.You will be an active part of the CMC project team, which includes:Defining the right formulation strategy and design and lead formulation development activitiesClose collaboration and coordination of work carried out in collaboration with CRO/CMO s.Responsible for setting up and reporting formulation and process development work and ensure proper documentation both for internal and regulatory purposes.Scientific responsibility for IMP productions in various scales in close collaboration with GMP personnel will also be part of your tasks.Share scientific knowledge and technological understanding with dedicated colleagues across the organization to support our projects.You are expected to continuously build on your scientific knowledge and expertise to propose new areas to explore and expand our scientific know-how.The job will require you to have creative and strategic skills to solve complex scientific challenges in an environment where prerequisites and timelines may change overnight. You will work with a wide variety of exciting activities in close collaboration with colleagues in your team and across the organization.Qualifications Our preferred candidate has the following personal and professional qualifications:You hold a PhD or a MSc within pharmaceutical science, engineering or another relevant scientific disciplineYou must have a minimum of 7 years of relevant experience and proven scientific skills within drug product development for biologics productsPossess a deep understanding of the different formulation development phases including knowledge about regulatory and quality aspects of drug development projects.  You are experienced in leading development activities, result-oriented and able to manage problem solving in a structured manner and find innovative solutions if needed.As a person you possess a personal drive, a positive mind-set and enjoy working in a busy and team based environment.You strive to set high scientific standards and are attentive to details and good documentation standards.You work well in teams and interact easily with people on all levels. You thrive equally well as backing to others or as leader of development activities.You have excellent communication skills both verbally and written (English).Further informationFor further information, please contact Senior Director of Pharmaceutical R&D Frank H


Region Hovedstaden Copenhagen

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