Location: Italy
Role Purpose:
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 include 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.
Role Responsibilities:
Lead the development of formulations and manufacturing processes of Drug ProductsSupport 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 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.Role RequirementsEssential 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).
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