RLT Analytical Product Project Leader (m / f / d)

Novartis Farmacéutica; Torino; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading company in radiopharmaceuticals seeks an Analytical Product Project Leader to manage project strategy and analytical activities. Candidates should have a PhD in chemistry or pharmaceutical technology with at least 5 years of experience in the industry. The role requires strong project management skills and proficiency in GMP principles, contributing to the advancement of nuclear medicine solutions for cancer treatment.

Competenze

• Minimum 5 years of industry experience in analytical chemistry.
• Experience in writing CMC documents for regulatory submissions.
• Proficiency in regulatory and quality expectations in radiopharmaceuticals.

Mansioni

• Lead and manage the analytical project strategy and high-quality submission documents.
• Coordinate analytical activities across all sites.
• Create and document a control strategy with partnering functions.

Conoscenze

Pharmaceutical technology

Analytical chemistry

Project management

Fluent English

GMP principles

Formazione

PhD in chemistry or pharmaceutical technology

Descrizione del lavoro

RLT Analytical Product Project Leader (m / f / d)

Job ID : REQ-10015150

Location : Ivrea, Italy

Summary

Role Purpose : Define, lead, and manage the analytical project strategy, including the overall analytical control strategy for Drug Substance(s) and radiopharmaceutical parenteral Drug Product(s) in line with the overall CMC project development plan. Ensure the creation of high-quality analytical submission documents. Support and mentor analytical team members, contributing to the overall Technical Research and Development strategies and goals.

Role Responsibilities :

1. Define and develop a science and quality-driven analytical project strategy, including contingency plans and risk evaluations for RLT DS and RLT DP.
2. Ensure transparent communication with management and relevant project team members.
3. Be a core member of the TRD sub-team representing RLT Analytical Science; co-own the technical development with the DSPL and RLT DPPL, and contribute to the technical development plan.
4. Lead and coordinate analytical activities (such as method development and validation, stability, release, reference nomination, and transfer) across all analytical sites and partnering functions.
5. Drive the testing strategy of RLT DS / DP and specifications setting. Represent RLT Analytical Science in peer reviews, governance boards, audits, etc.
6. Support resource planning, forecast & monitoring, ensuring budget adherence.
7. Create and document a high-quality control strategy with partnering functions, including risk assessments and documentation.
8. Handover analytical documents to internal and external partners, support outsourcing projects, and contribute to QA agreements.

Minimum Requirements :

1. PhD in chemistry, pharmaceutical technology, or equivalent with at least 5 years of industry experience in analytical chemistry, radiochemistry, quality control, and project management.
2. Fluent in English (oral and written); knowledge of site language is desirable.
3. Proficiency in GMP principles and understanding of regulatory and quality expectations in radiopharmaceuticals.
4. Experience in writing CMC documents for regulatory submissions and responding to health authority inquiries.
5. Experience with outsourcing, CROs, and CMOs, including technical oversight.
6. Awareness of safe handling of chemicals and hazardous materials.

Why Advanced Accelerator Applications?

Our mission is to transform lives through radioligand therapy in nuclear medicine to fight cancer. We believe innovation at the intersection of medical science and digital technology, along with a diverse and inclusive environment, drives success. Our culture is underpinned by integrity, curiosity, and flexibility, aiming to tackle the world's toughest medical challenges.

Imagine what you could do at Novartis!

We are committed to building an inclusive work environment and diverse teams that reflect the communities we serve.

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