Formulation Development Project Manager

4 settimane fa

Roma, Lazio, Italia Novartis Farmacéutica A tempo pieno

Job Summary

As a Formulation Development Project Manager at Novartis Farmacéutica, you will lead the development of formulations and manufacturing processes of Drug Products. You will work closely with operations, analytics, engineering, and relevant SMEs, QA, and the project DPPL to create and drive scientific and technological excellence in formulation development.

Key Responsibilities

  • Lead the development of formulations and manufacturing processes of Drug Products.
  • Support the development and qualification of analytical methods together with the AS&T team leader in accordance with ICH guidelines and internal SOPs.
  • Participate as a formulation expert to cross-functional project teams.
  • Be accountable for all formulation and manufacturing process deliverables, including scientific documentation for all assigned projects.
  • 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.
  • 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, Module 3/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, the TRD DPPL, and/or to any other relevant project team member.

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 of 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 setup.
  • Experience in writing CMC documents for regulatory submissions and responding to Health Authority questions.
  • Good basis of Quality Assurance (overall knowledge of GxPs).

About Novartis

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We believe that our employees are our greatest asset, and we strive to provide a work environment that is collaborative, innovative, and supportive of our employees' growth and development.

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