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Junior RA CMC

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Kelly Scientific Geneva is looking for a great Biopharmaceutical company a Junior RA_ CMC activities (100%) PERMANENT Position


Mission: Development of pharmaceutical drug substances and drug products throughout the product lifecycle.

The Junior RA will directly report to the Pharmaceutical Development Manager.


• Assist the management to establish the global product development strategy (Dev Plan / Dev budget / Dev timelines)
• Screen and assess external partners for CMC sub-contracted activities (API manufactures, CMOs, CROs, analytical laboratories, etc.)
• Plan, coordinate and implement CMC activities within the agreed budgets and timelines at the selected external partners
• Prepare and write high quality pharmaceutical dossiers (CMC M3 and M23) and manage the follow-up of the CMC sections in company Document Management System
• Respond to quality and clinical (BE) questions from authorities
• Provide technical support in case of manufacturing or quality issues, closely linked to QA and RA departments (OOS, Change controls, etc.)
• Technical due-diligence of in-licensing CMC dossiers
• Collaboration to patents' drafting and evaluation
• Technical-regulatory intelligence

Education, EXPERIENCE & Skill Requirements

• PharmD. or related scientific university degree with pharmaceutical specialization
• 1 to 3 years of experience working in development or regulatory within a pharmaceutical company
• Knowledge of pharmaceutical regulation, development, formulation and manufacturing skills
• Understanding of quality and regulatory issues (Drug substance and Drug Product)
• Good English communication skills, both in written and spoken
• Team player
• Keen on working in an international environment within a growing company
• Willingness to travel

Mathilde Dromard, Consultant Professional Staffing Life Science | PhD in Biology and Health | Kelly Services (Suisse) SA, Rue du Rhône 114, 1204 Genève, Switzerland
Contact :
Region: Genève
Vertragsart: Dauerhaft
Kategorie: Strategie & Management;
Veröffentlicht am: 22.09.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1409-15716
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
Helyek Külföld
Kategória Külföldi munka
Aktiválás időpontja 2014.10.24.
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