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RLT Formulation Project Leader

RLT Formulation Project Leader
Novartis Farmacéutica
Ivrea
EUR 50.000 - 70.000
Vacante urgente
Ayer
Quiero recibir las últimas vacantes disponibles de puestos de “Docente Inglese”

Information/Digital Technology Manager - Demand Planning (Oracle)

Information/Digital Technology Manager - Demand Planning (Oracle)
Experteer Italy
Firenze
EUR 50.000 - 80.000
Vacante urgente
Ayer

Export Manager Gioielli

Export Manager Gioielli
Suitex International
Valenza
EUR 50.000 - 70.000
Vacante urgente
Ayer

Field Service Technician

Field Service Technician
Carrier
Sacile
EUR 30.000 - 40.000
Vacante urgente
Ayer

Power Electronics Engineer

Power Electronics Engineer
Xylem
Alessandria
EUR 35.000 - 50.000
Vacante urgente
Ayer
Descubre más oportunidadesque en ningún otro sitio.
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Tecnico Qualità – Sala Prove Motore e Powertrain - Settore difesa

Tecnico Qualità – Sala Prove Motore e Powertrain - Settore difesa
ADECCO ITALIA S.p.A.
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EUR 30.000 - 45.000
Vacante urgente
Ayer

Service & Maintenance Technician

Service & Maintenance Technician
IMCD Deutschland GmbH & Co KG
Bolonia
EUR 25.000 - 35.000
Vacante urgente
Ayer

STRATEGY CONSULTANT INSURANCE

STRATEGY CONSULTANT INSURANCE
Gruppo Excellence
Pavia
EUR 50.000 - 70.000
Vacante urgente
Ayer
HeadhuntersEntra en contacto con cazatalentos para acceder a vacantes similares

Project Engineer

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Gruppo Danieli
Genova
EUR 40.000 - 65.000
Vacante urgente
Ayer

Security Engineer

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Bending Spoons
Trento
EUR 105.000 - 135.000
Vacante urgente
Ayer

Customer Support Consultant - Italy

Customer Support Consultant - Italy
Axa Venture Partners
Firenze
EUR 30.000 - 50.000
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The Italian Sea Group S.p.A
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EUR 24.000 - 36.000
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ELI - Test Engineer
Leonardo
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Forvis Mazars spa
Bolonia
EUR 10.000 - 30.000
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Ayer

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Allcore spa
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EUR 40.000 - 60.000
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Ayer

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Hunters Group
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EUR 55.000 - 70.000
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Progeco NeXT
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EUR 40.000 - 60.000
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Ayer

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Intesa Sanpaolo
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EUR 30.000 - 50.000
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Application Engineer

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Garaventa Lift Srl
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Addetti alla Sicurezza - SIZIANO

Addetti alla Sicurezza - SIZIANO
Sicuritalia
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EUR 30.000 - 50.000
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agap2 Italia
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Customer Care Representative (L.68/99)

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EUR 40.000 - 60.000
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Alipay
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EUR 50.000 - 80.000
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Ayer

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RLT Formulation Project Leader

Sé de los primeros solicitantes.
Novartis Farmacéutica
Ivrea
EUR 50.000 - 70.000
Sé de los primeros solicitantes.
Ayer
Descripción del empleo

Create and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation.

About the Role
Role Responsibilities:
  • Lead the development of formulations and manufacturing processes of Drug Products
  • Support the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs. Participate as formulation expert to cross-functional project teams.
  • Be accountable for all formulation and manufacturing process deliverables incl. scientific documentation for all assigned projects (Manufacturing instructions, GMP documents, deviation..).
  • Guarantee technical support answering DP related questions in inspections and Health Authority requests throughout all phases of the project life cycle.
  • Participate to the transfer manufacturing procedures to the relevant department (e.g. Technical Operations, CDMO, etc.).
  • Ensure authoring of accurate, comprehensible, structured, complete and legible documents to allow timely start of development trials, process transfers and supply activities.
  • Draft the CMC documents required to enable regulatory submissions (IND/IMPD, Module3/NDA).
  • Provide technical guidance to team members and work according to appropriate SOPs, GLP, GMP, HSE and AdAcAp / Novartis guidelines.
  • Proactively communicate key issues and any other critical topic in a timely manner to the appropriate management level, to the TRD DPPL and/or to any other relevant project team member.
  • Minimum: PhD in Pharmaceutics or related sciences with a minimum of 3 years of proven experience within the pharmaceutical/biotech industry or a Master’s degree with a minimum of 5 years experience.
  • Fluent knowledge of English (oral and written). Desirable knowledge of site language.
  • Demonstrated success in developing formulations with an emphasis in liquid sterile dosage forms.
  • Technical expertise and detailed understanding of drug product production and control technologies.
  • Experience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up.
  • Experience in writing CMC documents for regulatory submissions and responding to health authority questions.
  • Good basis of Quality Assurance (overall knowledge of GxPs).

Work Experience:

  • Functional Breadth.
  • Operations Management and Execution.

Skills:

  • Experiments Design.
  • Health And Safety (Ehs).
  • Laboratory Equipment.
  • Manufacturing Process.
  • Process Simulation.
  • Project Management.
  • Sop (Standard Operating Procedure).
  • Technical Writing.

Languages :

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl

Functional Area Research & Development

Job Type Full time

Employment Type Regular

Shift Work No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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* El índice de referencia salarialse calcula en base a los salarios que ofrecen los líderes de mercado en los correspondientes sectores. Su función es guiar a los miembros Prémium a la hora de evaluar las distintas ofertas disponibles y de negociar el sueldo. El índice de referencia no es el salario indicado directamente por la empresa en particular, que podría ser muy superior o inferior.

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