RLT Formulation Project Leader

Novartis Italia; Ivrea; In loco; EUR 50.000 - 90.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a formulation expert to lead the development of drug products. This role involves collaborating with cross-functional teams to ensure high-quality formulation and manufacturing processes. You will be responsible for drafting essential regulatory documents and providing technical guidance throughout project phases. Join a passionate community dedicated to creating breakthroughs that improve lives and make a meaningful impact in the pharmaceutical industry. This is a unique opportunity to contribute to innovative solutions in a collaborative environment.

Competenze

• PhD or Master's in Pharmaceutics with relevant industry experience.
• Proven success in developing liquid sterile dosage forms.

Mansioni

• Lead formulation and manufacturing processes for Drug Products.
• Draft CMC documents for regulatory submissions.

Conoscenze

Formulation Development

Analytical Methods

GMP Compliance

Technical Documentation

Project Management

Formazione

PhD in Pharmaceutics

Master's Degree in Related Sciences

Strumenti

CMC Documentation

Quality Assurance Systems

Descrizione del lavoro

Summary

Create and drive formulation development with scientific and technological excellence 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 development documents, and manufacturing instructions for technical and GMP manufacturing, including deviation handling.

About The Role

Role Responsibilities:

1. Lead the development of formulations and manufacturing processes of Drug Products.
2. Support the development and qualification of analytical methods with the AS&T team leader in accordance with ICH guidelines and internal SOPs. Participate as formulation expert in cross-functional project teams.
3. Be accountable for all formulation and manufacturing process deliverables, including scientific documentation (Manufacturing instructions, GMP documents, deviations).
4. Guarantee technical support during inspections and Health Authority requests throughout all project phases.
5. Participate in transferring manufacturing procedures to relevant departments (e.g., Technical Operations, CDMO).
6. Ensure authoring of accurate, comprehensible, structured, complete, and legible documents to enable timely development trials, process transfers, and supply activities.
7. Draft CMC documents required for regulatory submissions (IND/IMPD, Module 3/NDA).
8. Provide technical guidance to team members and ensure compliance with SOPs, GLP, GMP, HSE, and AdAcAp/Novartis guidelines.
9. Proactively communicate key issues and critical topics to management, TRD DPPL, and relevant project team members.

Essential Requirements

1. Minimum: PhD in Pharmaceutics or related sciences with at least 3 years of experience in the pharmaceutical/biotech industry, or Master’s degree with at least 5 years of experience.
2. Fluent in English (oral and written); knowledge of site language is desirable.
3. Proven success in developing formulations, especially liquid sterile dosage forms.
4. Technical expertise in drug product production and control technologies.
5. Experience outsourcing and supervising CRO/CMO work, including technical oversight of agreements.
6. Experience in writing CMC documents for regulatory submissions and responding to health authority inquiries.
7. Basic knowledge of Quality Assurance and GxPs.

Why Novartis

Helping people with disease and their families requires more than science. It takes a community of passionate, collaborative individuals like you. Join us to create breakthroughs that change lives. Learn more

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