RLT Analytical Product Project Leader
4 giorni fa
RLT Analytical Product Project Leader (m/f/d) Job ID: REQ-10015150
Location: Ivrea, Italy
Jul 11, 2024
Summary Role 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; ensure project specific high quality analytical submission documents. Support / mentor analytical team members and thereby contribute to the overall Technical Research and Development strategies and goals.
About the Role Role responsibilities: Define and develop an overall science and quality driven analytical project strategy including contingency plans and risk evaluations for RLT DS and RLT DP.
Ensure transparent communication to the appropriate management level and/or to any other relevant project team member(s).
Be a core member of the TRD sub-team representing RLT Analytical Science; co-own the technical development together with the DSPL and RLT DPPL, actively contribute to the definition of the overall technical development plan.
Lead & coordinate, together with RLT analytical experts and subject matter experts, analytical activities (such as method development and validation, DS/DP stability, DS/DP release, reference nomination and transfer activities) across all analytical sites and partnering functions.
Accountable for driving the testing strategy of RLT DS/DP and specifications setting. Be the RLT Analytical Science project representative in peer review and governance boards as well as in internal and external audits.
Support the assessment, forecast & monitoring of monthly resource needs and reflect in TRD planning tools (internal/external costs and FTE requirements) ensuring budget adherence.
Ensure the creation of an overall high-quality control strategy with partnering functions (CHAD, PHAD) and the documentation of the analytical/testing control strategy (e.g. SSS, risk assessments).
Accountable for handover of analytical documents to internal and external partners (for e.g., including Health authority questions/CMC modules/Manufacturing & supply operations etc.) Understand & actively lead the interactions of project related RLT analytical activities across sites and line functions. Support EPM colleagues in outsourcing projects and provide input to QA agreements.
Minimum Requirements: PhD in chemistry, pharmaceutical technology, or equivalent scientific degree with minimum 5 years of successful industry experience in the field of analytical chemistry and/or radiochemistry development and/or quality control with project management experience.
Fluent knowledge of English (oral and written). Desirable knowledge of site language.
Proficiency in quality principles driving drug development such as GMP; clear understanding of current and anticipated regulatory and quality expectations preferably in the radiopharmaceutical industry.
Strong experience in writing CMC documents for regulatory submissions and responding to health authority questions.
Strong experience with outsourcing and coordinating work done by CRO/CMOs including technical overview of agreement set up.
Awareness for safe handling of chemicals, potentially dangerous materials, and equipment.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do at Novartis
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Job ID: REQ-10015150
RLT Analytical Product Project Leader (m/f/d)
#J-18808-Ljbffr
-
RLT Analytical Product Project Leader
4 giorni fa
Roma, Italia CDS Analytical A tempo pienoRLT Analytical Product Project Leader (m/f/d) Job ID REQ-10015150 Jul 11, 2024 Italy Summary Location: Ivrea, Italy Role 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...
-
RLT Formulation Project Leader
4 giorni fa
Roma, Italia Project Bauteam A tempo pienoCreate 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...
-
RLT Formulation Project Leader
4 giorni fa
Roma, Italia Novartis Farmacéutica A tempo pienoCreate 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...
-
RLT Formulation Project Leader
4 giorni fa
Roma, Italia Advanced Accelerator Applications (Italy) - S... A tempo pienoCreate 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 include, among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and...
-
Project Leader Junior
2 ore fa
Roma, Italia Project Automation S.p.A. A tempo pienoProject Automation, leading company nella “Ingegneria dei sistemi di telemisura, supervisione e controllo”, nell’ambito del potenziamento dell’organico della propria filiale di Roma ricerca: **_PROJECT LEADER JR._** **Posizione professionale** **Titolo di studio** E' richiesta la laurea in ingegneria (elettronica / telecomunicazioni / gestionale)...
-
Product Portfolio Strategist
1 settimana fa
Roma, Lazio, Italia Product Heroes A tempo pienoDescrizione del Lavoro:Nell'ambito della nostra squadra di Product Heroes, siamo alla ricerca di un prodotto portfolio strategista che si occupi della gestione e supervisione di un portafoglio di circa 20 prodotti software e hardware.Ruoli e Responsabilità:Gestione del Portafoglio Prodotti: sviluppo e implementazione di strategie di portafoglio per...
-
RLT Formulation Project Lead Specialist
1 settimana fa
Roma, Lazio, Italia Novartis Farmacéutica A tempo pienoAbout the RoleAs a key member of our formulation team, you will be responsible for driving the development of innovative formulations and manufacturing processes for drug products. Your expertise in formulation development and process design will enable us to deliver high-quality products that meet the needs of patients.Key ResponsibilitiesLead the...
-
Product Engineering Leader
1 settimana fa
Roma, Italia Music Tribe A tempo pieno**Our Tribers**: **Our Brands**: **Our Music Tribe City**: **Roles and Responsibilities**: **You are Aligned with our Purpose**: At Music Tribe, we believe that empowering our Tribers and Brands will create life-changing Customer Happiness. **Our Values**: - Be Kind - Be Clear - Collaborate - Deliver to Promise - Celebrate **You** **will** Envision and...
-
Project Leader
4 giorni fa
Roma, Italia Exelab S.r.l A tempo pienoExelab is a system integrator specializing in CRM solutions that enable companies to enhance performance through process automation. We like to go beyond execution, understanding the real needs of the customer and identifying solutions that deliver the greatest value. The people working at Exelab share this goal and work every day to achieve it. This is...
-
Product Visionary Leader
1 ora fa
Roma, Lazio, Italia CAST Software A tempo pienoCAST Software Overview">CUTTER uses advanced technology to assist clients in creating better software, resulting in significant time and financial savings. We collaborate with some of the world's most prestigious companies, offering bespoke services tailored to their unique needs.">Our multidisciplinary staff is comprised of skilled software engineers,...
-
Product Management Intern
12 ore fa
Roma, Lazio, Italia Lenovo A tempo pienoWe are Lenovo, a global technology leader driven by innovation and customer satisfaction. Our product teams are at the forefront of shaping our company's future.The Product Management Intern will play a key role in supporting our Product Team in Italy. This exciting opportunity involves a diverse range of responsibilities, including:Assisting with business...
-
ELECTRICAL PROJECT LEADER
4 giorni fa
Roma, Italia Tecnimont A tempo pienoHe/She is responsible for the activities pertaining to the discipline within a project, in compliance with the assigned budget, the project schedule, and the technical requirements, assuring cost optimization. The Project Leader leads a group of specialists and/or engineers appointed to the project by the Head of Department and reports to the Project...
-
ELECTRICAL PROJECT LEADER
6 ore fa
roma, Italia Tecnimont A tempo pienoHe/She is responsible for the activities pertaining to the discipline within a project, in compliance with the assigned budget, the project schedule, and the technical requirements, assuring cost optimization. The Project Leader leads a group of specialists and/or engineers appointed to the project by the Head of Department and reports to the Project...
-
Product Portfolio Leader, Musical Instruments
1 settimana fa
Roma, Italia Music Tribe A tempo pieno**Our Tribers**: **Our Brands**: **Our Music Tribe City**: **Roles and Responsibilities**: **You are Aligned with our Purpose**: At Music Tribe, we believe that empowering our Tribers and Brands will create life-changing Customer Happiness. **Our Values**: - Be Kind - Be Clear - Collaborate - Deliver to Promise - Celebrate **You** **will** Envision and...
-
Project Manager
4 giorni fa
Roma, Italia Project Redirect Inc Of The Distric A tempo pienoSeeking a Project Manager to lead software development projects, ensuring timely, on-budget delivery aligned with client expectations. This key role involves effective coordination, communication, and leadership for successful project outcomes. Must-Have Skills: Project Management: Proven experience in project management methodologies and tools. ...
-
Product Owner- Remote
2 giorni fa
Roma, Italia Westlink A tempo pienoWestLink is a leading software development agency committed to being holistic development partners, not just vendors. Our entrepreneurial spirit drives us to deliver exceptional software solutions by fostering collaboration, accountability, creativity, and adaptability. We value a culture of knowledge-sharing, leadership, and ownership, all while maintaining...
-
Project Leader
12 ore fa
Roma, Lazio, Italia Michael Page A tempo pieno**Job Summary:**We are seeking an experienced Project Director to lead our luxury hospitality project development process from acquisition of new land, design and development, to construction of all infrastructure and buildings.A leader in the high-income real estate sector with significant operations in hospitality and real estate development, this role...
-
Analytical Solutions Developer
1 ora fa
Roma, Lazio, Italia Group M Worldwide Inc. A tempo pienoAbout Our TeamOur team at Group M Worldwide Inc. is comprised of individuals from diverse backgrounds, experiences, and identities, working together to drive innovation and growth for our clients through data-driven decision making.Job DescriptionWe are seeking a highly motivated Data Analysis Intern to join our team and contribute to the development of...
-
Virtual Product Discipline Leader
4 giorni fa
Roma, Italia SISAL A tempo pienoSisal S.p.A ricerca per la propria sede di Roma, un/a Virtual Product Discipline Leader da inserire all’interno della BU Betting, a riporto del Virtual Platform & Product Senior Manager.- Gestione e sviluppo dei prodotti;- Gestione dei fornitori di piattaforma;- Gestione documentazione e rapporti con ADM/Sogei per lancio nuovi prodotti/modifiche di...
-
Roma, Lazio, Italia Product Heroes A tempo pienoProduct Heroes, un leader globale nella tecnologia e nell'innovazione dei servizi aziendali, è alla ricerca di un professionista con esperienza in Product Portfolio Management. La posizione si trova all'interno del team di NTT Data, una società che offre soluzioni integrate per l'innovazione digitale.Descrizione del LavoroIl responsabile del portafoglio...
