TRD Principal Scientist, Late Theragnostic Development

Oct 04, 2021

Job Description

Job Purpose

Coordinate and provide technical oversight for the generation of the technical package of CMC dossiers in support of clinical trial and marketing authorisation submissions (IND/IMPD, MAA/NDA) as well as for the life cycle management of drug products in pipeline.

Main Activities
• Serve as line function representative in cross-functional project teams
• Lead the development of formulations and manufacturing processes of Drug Products Lead the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs
• Participate to the transfer of analytical and manufacturing procedures to the Technical Operations.
• Draft the CMC documents required for enabling regulatory submissions (IND/IMPD, Module3/NDA).
• Provide technical guidance to team members and work according to appropriate SOP’s, GLP, GMP, OQM, HSE, ISEC and AAA / Novartis guidelines

Diversity & Inclusion / EEO

Novartis si impegna a costruire un ambiente di lavoro eccellente e inclusivo e un team diversificato che rappresenti i pazienti e le comunità che serviamo.

Minimum Requirements

Education: Minimum: PhD in chemistry or pharmaceutical chemistry with a minimum of 3 years of relevant experience within the pharmaceutical/biotech industry or a Master’s degree in chemistry or pharmaceutical chemistry with a minimum of 5 years of experience

Languages: Good knowledge of English (oral and written). Desirable knowledge of site language

Experience / Professional requirements: • Demonstrated success in developing formulations
• Technical expertise and thorough understanding of drug product production and control technologies
• Experience in writing documents for regulatory submissions and responding to health authority questions
• Good basis of Quality Assurance (overall knowledge of GxPs)
• Good presentation skills and scientific/technical writing skills
• Good communication skills, basic coaching skills
Colleretto Giacosa
Full Time
Tempo Indeterminato
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TRD Principal Scientist, Late Theragnostic Development

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