54 days ago on sjobs.brassring.com

Principal Scientist for Formulation and Process Development of Protein

Novartis Pharma Schweiz AG

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Principal Scientist for Formulation and Process Development of Protein

Job ID 219724BR Position Title Principal Scientist for Formulation and Process Development of Protein Division Novartis Technical Operations Business Unit NTO BTDM Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Scientist for formulation and process development of protein drug products with experience in the development of filing processes.
In this challenging role, you will develop parenteral dosage forms and manufacturing processes for therapeutic proteins including the transfer to pilot plant and production. We rely on you to achieve robust formulations and processes through optimization and provide the required documentation to allow worldwide IND/BLA registration. The successful candidate will lead and manage all pharmaceutical drug product development activities for assigned projects within the Biologics Technical Development and Manufacturing Biopharmaceutical Product and Process Development (BTDM-BPD) Late Phase Section, lead the drug product team (functional experts) and represent PHD on the CMC sub team. As senior expert in the field you will support colleagues with scientific and strategic advice and take a leading role in project troubleshooting activities. You will be working in multidisciplinary and international teams and represent Pharmaceutical Development in external collaborations, which results in a wide range of scientific and strategic tasks. The Development of new processing technologies and supervision of scientific projects are further optional within this position.
Minimum requirements Ph.D. in Science (e.g. Pharmacy, Chemistry) with focus on pharmaceutical technology OR professional experience of at least 5 years in formulation and process development of parenteral protein drug pro Strong communication skills. Excellent English required (oral & written). Good skills in site (local) language desired (oral). experience in the development of filing processes, expert knowledge in protein formulation is desired, protein analytics and GMP systems is of advantage. Broad experience in GMP parenteral drug product manufacturing and in the respective regulatory field is desired. Interdisciplinary thinking, high motivation to work in international teams and within flat hierarchies. Excellent organizational and planning abilities. Relevant experience in technical project management and leading of scientific teams.