Senior LNP Process Development Scientist (Remote)

Biopharma Careers; Italia; Ibrido; EUR 53.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare benefits

Pension plan

Wellbeing programme

Flexible benefits

Relocation support

Remote work options

Descrizione del lavoro

Chiesi is looking for a senior scientist to lead formulation development for LNP platforms across Europe, coordinating CRO/CDMO activities and ensuring rigorous technical governance. The role requires strong DoE know-how, GMP experience, and hands-on writing of protocols and regulatory documentation.

You will work within the GRD R&D team, contributing to development plans, risk assessments, and lifecycle management while supporting BD opportunities and budget oversight.

Competenze

• MSc in a relevant field is required.
• Strong expertise in formulation screening and process development.
• Experience with outsourcing (CROs/CDMOs) and regulatory documentation.

Mansioni

• Define and lead the development plan for LNP formulations and screening.
• Oversee the LNP development workstream for technology transfers.
• Screen CROs/CDMOs and support auditing/qualification.
• Provide technical governance and oversight of external partners.
• Lead root cause investigations and deviation assessments.
• Review batch records, SOPs and development reports from CDMOs.
• Manage budgets for CROs/CDMOs and consultants.
• Contribute to CMC strategy and regulatory alignment.
• Write and review protocols, reports, stability studies, and CQAs.

Conoscenze

Formulation screening

Process development

Scale-up

Tech transfer

DoE

CPP/CQA identification

GMP knowledge

Regulatory documentation

Formazione

MSc in Biotechnology/biochemistry/chemical engineering

Descrizione del lavoro

Chiesi is looking for a senior scientist to lead formulation development for LNP platforms across Europe, coordinating CRO/CDMO activities and ensuring rigorous technical governance. The role requires strong DoE know-how, GMP experience, and hands-on writing of protocols and regulatory documentation.

You will work within the GRD R&D team, contributing to development plans, risk assessments, and lifecycle management while supporting BD opportunities and budget oversight.