RLT Formulation Project Leader

3 mesi fa


Ivrea TO, Italia Novartis A tempo pieno

Summary
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 ICH guidelines and internal SOPs. Participate as formulation expert in 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 topic in a timely manner to the appropriate management level, to the TRD DPPL and/or to any other relevant project team member.

Essential Requirements:

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 on 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.

Collaborating across boundaries.

Skills:

Environment.

Experiments Design.

Health And Safety (EHS).

Laboratory Equipment.

Manufacturing Process.

Materials Science.

Process Simulation.

Project Management.

SOP (Standard Operating Procedure).

Technical Writing.

Languages:

English.

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.

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.

Division: International

Business Unit: Innovative Medicines

Location: Italy

Site: Ivrea

Company / Legal Entity: IT58 (FCRS = IT058) AAA 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.

#J-18808-Ljbffr



  • Ivrea, Italia Novartis A tempo pieno

    Summary 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...


  • Ivrea (TO), Italia Novartis Farmacéutica A tempo pieno

    RLT Analytical Product Project Leader (m/f/d) Job ID: REQ-10015150 Jul 11, 2024 Location: Ivrea, Italy 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...


  • Ivrea (TO), Italia Novartis Farmacéutica A tempo pieno

    RLT 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...


  • Ivrea (TO), Italia Novartis A tempo pieno

    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 development plan; ensure project specific high quality analytical submission documents. Support...


  • Ivrea, Italia Novartis Farmacéutica A tempo pieno

    RLT Analytical Product Project Leader (m/f/d)Job ID: REQ-10015150Jul 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; ensure...


  • Ivrea, Italia Novartis A tempo pieno

    SummaryLocation: Ivrea, ItalyRole 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 /...

  • RLT Analytical Expert

    4 settimane fa


    Ivrea, Italia Novartis Farmacéutica A tempo pieno

    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

    3 settimane fa


    Ivrea, Italia Novartis A tempo pieno

    SummaryLocation: 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...


  • Ivrea (TO), Italia Novartis A tempo pieno

    Summary Location: Ivrea, Italy Role 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...


  • Ivrea, Italia Novartis A tempo pieno

    **Summary**: Location: Ivrea, Italy Role Purpose: Leads the site’s Manufacturing Functions organization (RLT Pilot Plant) which ensures that equipment, infrastructure and manufacturing area are fully operational, meet regulatory, GMP and HSE compliance and are further developed to meet future requirements and business needs. Lead TRD RLT Pilot Plant to...


  • Ivrea, Italia Novartis A tempo pieno

    SummaryLocation: 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...

  • Automation Engineer

    5 giorni fa


    Ivrea (TO), Italia Novartis Farmacéutica A tempo pieno

    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. In...


  • Ivrea (TO), Italia Novartis A tempo pieno

    Summary 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...

  • Automation Engineer

    4 settimane fa


    Ivrea, Italia Novartis Farmacéutica A tempo pieno

    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. In this...


  • Ivrea, Italia Novartis A tempo pieno

    SummaryNovartis 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....

  • Team Leader

    7 mesi fa


    Ivrea, Italia Message A tempo pieno

    Se hai esperienze e competenze nel mondo della valorizzazione del brand, della comunicazione multicanale per medie-grandi aziende, della creatività gráfica e della ideazione visual, nella gestione dei contenuti o nel project management di progetti complessi, hai l’opportunità di mettere tutto ciò al servizio di una realtà in forte crescita in un...


  • Ivrea, Italia Novartis A tempo pieno

    **Summary**: TRD Quality Process & Engineering Manager will collaborate with RLT Engineering organization for RLT TRD, to establish, maintain and improve the engineering processes with respect to buildings, equipment, utilities and energy. This role includes oversight of operational and validation activities and continuous process improvements. **About the...


  • Ivrea, Italia Dayco Europe Srl A tempo pieno

    115 years of experience, 40 locations in 22 countries: these are the keys for our global success and this is what the new **Product Leader E-Bike** will experience in his journey with Dayco Propulsion Solutions. Dayco Propulsion Solutions works as a Global Team every day to raise the bar and provide more and more integrated solutions for Hybridization,...

  • Project Manager

    2 mesi fa


    Beinasco (TO), Italia Soft-in A tempo pieno

    The ideal candidate is flexible , results and teamwork oriented . Good written and spoken English is mandatory for this role (at least as level B2 ). This position will be based in Beinasco (Turin, Italy). Responsibilities Project planning and tracking progress adhering to scope, quality, and timelines. Risk and Problem Management : Risk Log, Action...


  • Ivrea, Italia Novartis A tempo pieno

    **Summary**: The Site Operations Head is responsible for driving project management and operational excellence activities for the manufacturing site and within the RLT Network. The incumbent will be member of the Site Leadership Team and will assist the Site Strategic Planning Process and Production scheduling processes. The incumbent will own and provide...