RLT Formulation Project Leader

Novartis Farmacéutica; Ivrea; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Novartis is seeking an experienced professional in formulation development to drive scientific and technological excellence. This role involves collaborating with cross-functional teams, ensuring quality risk management, and authoring development documents for drug products. Ideal candidates will have a PhD or Master's in relevant fields and a strong background in the pharmaceutical industry.

Competenze

• Minimum PhD in Pharmaceutics with 3 years experience in biotech.
• Fluent in English, desirable knowledge of site language.
• Demonstrated success in developing liquid sterile dosage forms.

Mansioni

• Lead the development of formulations and manufacturing processes.
• Support analytical method development in accordance with ICH guidelines.
• Draft CMC documents for regulatory submissions.

Conoscenze

Experiments Design

Health And Safety (Ehs)

Laboratory Equipment

Manufacturing Process

Process Simulation

Project Management

Sop (Standard Operating Procedure)

Technical Writing

Formazione

PhD in Pharmaceutics or related sciences

Master's degree with 5 years experience

Descrizione del lavoro

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.
• 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.

Skills:

• Experiments Design.
• Health And Safety (Ehs).
• Laboratory Equipment.
• Manufacturing Process.
• Process Simulation.
• Project Management.
• Sop (Standard Operating Procedure).
• Technical Writing.

Languages :

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IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl

Functional Area Research & Development

Job Type Full time

Employment Type Regular

Shift Work No

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