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RLT Formulation Project Leader

AT Novartis
Novartis

RLT Formulation Project Leader

Ivrea, Italy

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 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.

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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 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.
  • 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? https://www.novartis.com/about/strategy/people-and-culture

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Division
International

Business Unit
Innovative Medicines

Location
Italy

Site
Ivrea

Company / Legal Entity
IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No

Client-provided location(s): 10015 Ivrea, Metropolitan City of Turin, Italy
Job ID: Novartis-REQ-10013628
Employment Type: Full Time