Senior Analytics Leader - CMC Method Validation (Remote)

Chiesi Farmaceutici S.p.A.; Parma; Ibrido; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT, seeks an experienced Senior Technical Leader for Analytical Method Development and Validation in GRD CMC.

You will lead analytical strategy, development plans, and lifecycle activities for biologics, partnering with CDMOs, CROs, and internal teams. You will guide method development, qualification, validation, and control strategies, ensuring alignment with regulatory expectations, quality systems, and project timelines.

Competenze

• Experience in analytical method development for biologics.
• Strength in method qualification and validation.
• Solid understanding of GMP and regulatory expectations for biologics development.

Mansioni

• Provide scientific and technical leadership for analytical CMC in GRD CMC.
• Lead or contribute to CMC strategies across development stages and lifecycle.
• Collaborate with internal functions, external CDMOs/CROs, and partners to drive development.
• Translate protein biology and process understanding into robust CMC strategies.
• Identify and manage critical quality attributes and product quality attributes.
• Drive risk-based CMC strategies and lifecycle knowledge management.

Conoscenze

Analytical method development

Method qualification and validation

GMP & regulatory

Biologics knowledge

Team leadership

Cross-functional collaboration

Formazione

Life sciences degree

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT, seeks an experienced Senior Technical Leader for Analytical Method Development and Validation in GRD CMC.

You will lead analytical strategy, development plans, and lifecycle activities for biologics, partnering with CDMOs, CROs, and internal teams. You will guide method development, qualification, validation, and control strategies, ensuring alignment with regulatory expectations, quality systems, and project timelines.