TRD Principal Scientist, Early Theragnostic Development

324378BR
Oct 07, 2021
Italy

Job Description

Job Purpose

Coordinate and provide technical oversight on the collaboration with External Partners as well as on the technical package generated with the aim of building the CMC sections of dossiers in support of clinical trial submissions (IND/IMPD, MAA/NDA).


Major 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 in accordance with ICH guidelines and with specific references to quality control of radiopharmaceuticals
• Lead the transfer of analytical or manufacturing procedures for ready to use radiopharmaceuticals to External Partner
• Review of External Partner Quality documents (e.g. Validation Reports and Batch Records)
• Draft the CMC documents required for enabling regulatory submissions (IND/IMPD,)
• Provide scientific and technical guidance. Coach team members as needed
• Give guidance to team members and work according to appropriate SOP’s, GLP, GMP, OQM, HSE, ISEC and AAA / Novartis guidelines.
• Actively interaction with other CMC team members for the achievement of project’s goals.

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

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.
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Italy
Colleretto Giacosa
Full Time
Tempo Indeterminato
No
324378BR

TRD Principal Scientist, Early Theragnostic Development

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