Senior Analytical Method Leader - Biologics & CMC (Remote)

Chiesi Farmaceutici S.p.A.; Parma; In loco; EUR 62.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation support

Healthcare program

Tax assistance for foreign colleagues

Flexible working arrangements

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT is seeking a Senior Technical Leader for Analytical Method Development and Validation in GRD CMC.

You will lead end-to-end analytical strategy, development, qualification, validation, and lifecycle activities for biologics projects, collaborating with internal teams and external partners. The role requires deep expertise in CMC, regulatory expectations, and strong leadership, with excellent English communication.

Competenze

• Proven experience in analytical development for CMC in biopharma.
• Experience with method qualification, validation and regulatory expectations.
• Strong English written and spoken communication.

Mansioni

• Provide scientific leadership for analytical CMC in GRD CMC.
• Lead analytical method development, qualification, and validation.
• Guide technology transfer and lifecycle activities.
• Collaborate with CDMOs, CROs, and internal partners.
• Support regulatory submissions and safety/compliance.

Conoscenze

Analytical method development

Method qualification

Validation

Analytical control strategy

Technology transfer

Regulatory submission

English communication

Formazione

University degree in biotechnology/biochemistry/chemistry/biology/pharmacy/engineering

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT is seeking a Senior Technical Leader for Analytical Method Development and Validation in GRD CMC.

You will lead end-to-end analytical strategy, development, qualification, validation, and lifecycle activities for biologics projects, collaborating with internal teams and external partners. The role requires deep expertise in CMC, regulatory expectations, and strong leadership, with excellent English communication.