Rlt Formulation Project Leader
1 mese fa
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 RoleRole Responsibilities:Lead the development of formulations and manufacturing processes of Drug ProductsSupport the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICH 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 in the transfer of 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 topics in a timely manner to the appropriate management level, to the TRD DPPL and/or to any other relevant project team member.Minimum Requirements: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.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?
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
#J-18808-Ljbffr
-
Rlt Formulation Project Leader
4 settimane fa
Montà, Italia Innovative Medicines A tempo pienoSummary 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...
-
Rlt Formulation Project Leader
2 settimane fa
Montà, Italia Innovative Medicines A tempo pienoSummary 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...
-
Rlt Analytical Product Project Leader
1 mese fa
Montà, Italia Novartis Farmacéutica A tempo pienoRLT Analytical Product Project Leader (m/f/d)Job ID: REQ-10015150Date: Jul 11, 2024Location: Ivrea, ItalySummaryRole Purpose: Define, lead and manage the analytical project strategy including the overall analytical control strategy for Drug Substance(s) and radiopharmaceutical parenteral Drug Product(s) in line with the overall CMC project development plan;...
-
Rlt Analytical Expert
1 mese fa
Montà, Italia Novartis Farmacéutica A tempo pienoLocation: Ivrea, ItalyRole Purpose: Design and plan scientific experiments as well as report and interpret results/outcome in line with the overall TRD RLT project strategy for RLT Drug Substance(s) and Drug Product(s) in development. Ensure project knowledge generation and preparation/timely delivery of supplies with high quality and state of the art...
-
Rlt Analytical Expert
1 mese fa
Montà, Italia Innovative Medicines A tempo pienoSummary Location: Ivrea, ItalyRole Purpose:Design and plan scientific experiments as well as report and interpret results/outcome in line with the overall TRD RLT project strategy for RLT Drug Substance(s) and Drug Product(s) in development. Ensure project knowledge generation and preparation/timely delivery of supplies with high quality and state of the art...
-
Rlt Analytical Expert
2 settimane fa
Montà, Italia Innovative Medicines A tempo pienoSummary Location: Ivrea, Italy Role Purpose: Design and plan scientific experiments as well as report and interpret results/outcome in line with the overall TRD RLT project strategy for RLT Drug Substance(s) and Drug Product(s) in development. Ensure project knowledge generation and preparation/timely delivery of supplies with high quality and state of the...
-
Rlt Analytical Expert
2 settimane fa
Montà, Italia Innovative Medicines A tempo pienoSummary Location: Ivrea, ItalyRole Purpose:Design and plan scientific experiments as well as report and interpret results/outcome in line with the overall TRD RLT project strategy for RLT Drug Substance(s) and Drug Product(s) in development. Ensure project knowledge generation and preparation/timely delivery of supplies with high quality and state of the art...
-
Formulation Project Manager R&D
1 mese fa
Montà, Italia Nonstop Consulting A tempo pienoNonStop Pharma è alla ricerca di un Formulation Project Manager , con base in Piemonte, per un'azienda cliente. Sei alla ricerca di un contesto che valorizzi l'innovazione e l'eccellenza tecnologica? Questa e' la tua occasione per unirti a una delle aziende farmaceutiche piu' avanzate a livello globale, dove potrai beneficiare di un ambiente stimolante e...
-
Rlt Drug Product Project Lead
1 mese fa
Montà, Italia Novartis Farmacéutica A tempo pienoLocation: Ivrea, ItalyRole Purpose: Leads and manages all Drug Product (DP) project activities linked to the development of radiopharmaceutical parenterals (both ready to use and freeze dried products). Supports & coaches team members, participates in scientific teams and contributes to the overall Technical Research and Development strategies and goals....
-
Rlt Drug Product Project Lead
1 ora fa
Montà, Italia Novartis A tempo pienoSummary Location: Ivrea, ItalyRole Purpose: Leads and manages all Drug Product (DP) project activities linked to the development of radiopharmaceutical parenterals (both ready to use and freeze dried products). Supports & coaches team members, participates in scientific teams and contributes to the overall Technical Research and Development strategies and...
-
Formulation Scientist
1 mese fa
Montà, Italia Novartis Farmacéutica A tempo pienoLocation: Colleretto GiacosaRole Purpose: Plan, perform and report scientific experiments with SME (subject matter expert) to support the project portfolio and/or advance the innovation technical platform of radiopharmaceutical parenteral dosage forms. Contribute to maintenance of laboratory instruments/infrastructure.About the RoleRole Requirements:Plan...
-
Project Leader
1 settimana fa
Montà, Italia Manpowergroup A tempo pienoIl nostro Cliente: Storica azienda del cuneese, facente parte di un prestigioso gruppo mondiale e operante nel settore manufacturing/engineering. Ci ha incaricati di ricercare un/a: PROJECT LEADER Il lavoro: Siamo alla ricerca di una risorsa che si inserisca nel ruolo di Project Leader, che riporter a livello gerarchico al Project Manager Coordinator. Il...
-
Project Leader
1 settimana fa
Montà, Italia Manpower A tempo pienoIl nostro Cliente: Storica azienda del cuneese, facente parte di un prestigioso gruppo mondiale e operante nel settore manufacturing/engineering. Ci ha incaricati di ricercare un/a: PROJECT LEADER Il lavoro: Siamo alla ricerca di una risorsa che si inserisca nel ruolo di Project Leader, che riporterà a livello gerarchico al Project Manager Coordinator. Il...
-
Project Leader
1 ora fa
Montà, Italia Manpower A tempo pienoIl nostro Cliente: Storica azienda del cuneese, facente parte di un prestigioso gruppo mondiale e operante nel settore manufacturing/engineering.Ci ha incaricati di ricercare un/a:PROJECT LEADER Il lavoro: Siamo alla ricerca di una risorsa che si inserisca nel ruolo di Project Leader, che riporterà a livello gerarchico al Project Manager Coordinator.Il...
-
Formulation Scientist
4 settimane fa
Montà, Italia Innovative Medicines A tempo pienoSummary Location: Colleretto GiacosaRole Purpose:Plan, perform and report scientific experiments with SME (subject matter expert) to support the project portfolio and/or advance the innovation technical platform of radiopharmaceutical parenteral dosage forms. Contribute to maintenance of laboratory instruments/infrastructure About the Role Role Requirements:...
-
Formulation Scientist
2 settimane fa
Montà, Italia Innovative Medicines A tempo pienoSummary Location: Colleretto GiacosaRole Purpose:Plan, perform and report scientific experiments with SME (subject matter expert) to support the project portfolio and/or advance the innovation technical platform of radiopharmaceutical parenteral dosage forms. Contribute to maintenance of laboratory instruments/infrastructure About the Role Role Requirements:...
-
Formulation Scientist
2 settimane fa
Montà, Italia Innovative Medicines A tempo pienoSummary Location: Colleretto Giacosa Role Purpose: Plan, perform and report scientific experiments with SME (subject matter expert) to support the project portfolio and/or advance the innovation technical platform of radiopharmaceutical parenteral dosage forms. Contribute to maintenance of laboratory instruments/infrastructure About the Role Role...
-
Montà, Italia Novartis A tempo pienoSummary Novartis is at the forefront of transforming lives through radioligand therapy in nuclear medicine, combatting several prevalent cancer types. If you're passionate about pushing the boundaries of this industry and creating innovative, life-saving medicines for cancer patients, consider joining us as a Global Automation Engineer, Associate Director....
-
Montà, Italia Novartis Farmacéutica A tempo pienoGlobal Automation Engineer, Associate DirectorJob ID: REQ-10005251Date: Jul 23, 2024Location: ItalySummaryNovartis is at the forefront of transforming lives through radioligand therapy in nuclear medicine, combatting several prevalent cancer types. If you're passionate about pushing the boundaries of this industry and creating innovative, life-saving...
-
Project Manager Agro Business Unit
21 ore fa
Montà, Italia Silvateam S.P.A. A tempo pienoAt Silvateam, we're committed to providing innovative agricultural solutions that meet the evolving needs of farmers and the global agro-industry. To help drive our continued growth and product innovation, we're looking for a Project Manager to join our Agro Business Unit. The ideal candidate will have a proven ability to manage the entire product lifecycle,...
