RLT Formulation Project Leader

3 giorni fa

Ivrea, Piemonte, Italia Novartis A tempo pieno

Job Description 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.

Job Description

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.
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.

Skills Desired

Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model

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