Formulation Development Leader

2 settimane fa


Roma, Lazio, Italia Novartis Farmacéutica A tempo pieno

Job Summary: We are seeking a highly skilled Formulation Development Leader to join our team at Novartis Farmacéutica. As a key member of our formulation development team, you will be responsible for leading the development of formulations and manufacturing processes for drug products. This role requires a strong background in pharmaceutical sciences, with a focus on liquid sterile dosage forms. The ideal candidate will have a PhD in Pharmaceutics or a related field, with a minimum of 3 years of experience in the pharmaceutical industry.

Key Responsibilities:
Develop and drive formulation development strategies in close collaboration with operations, analytics, engineering, and relevant SMEs.
Lead the development of formulations and manufacturing processes for drug products.
Support the development and qualification of analytical methods in accordance with ICH guidelines and internal SOPs.
Participate in cross-functional project teams as a formulation expert.
Ensure the delivery of high-quality scientific documentation for all assigned projects.
Provide technical guidance to team members and ensure compliance with GMP, GLP, and HSE guidelines.

Requirements:
PhD in Pharmaceutics or a related field.
Minimum 3 years of experience in the pharmaceutical industry.
Strong knowledge of English (oral and written).
Demonstrated success in developing formulations with an emphasis on liquid sterile dosage forms.
Technical expertise in drug product production and control technologies.
Experience with outsourcing and supervising work done by CRO/CMOs.
Experience in writing CMC documents for regulatory submissions.
Good basis of Quality Assurance (overall knowledge of GxPs).

Why Novartis: At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We offer a collaborative and dynamic work environment, with opportunities for professional growth and development. If you are a motivated and experienced formulation development professional, we encourage you to apply for this exciting opportunity.



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