Rlt Formulation Project Leader Lazio

Rlt Formulation Project Leader
Roma
Lazio, Lazio

Advanced Accelerator Applications (Italy) - S. . .

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, among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture including 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 including scientific documentation for all assigned projects (Manufacturing instructions, GMP documents, deviation, etc. ).

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, 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 topics in a timely manner to the appropriate management level, to the TRD DPPL and/or to any other relevant project team member.

Minimum 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 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.

Skills: Experiments Design, Health And Safety (EHS), Laboratory Equipment, Manufacturing Process, Process Simulation, Project Management, SOP (Standard Operating Procedure), Technical Writing.

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