Senior Scientist, Container Closure Integrity Lead

Biopharma Careers; Schaffhausen; Hybride; CHF 140 000 - 190 000; Plein temps

Résumé du poste

Cilag AG is seeking a Senior Scientist to lead CCIT and SB IT projects within a GMP- regulated analytical development lab. You will drive method development, validation, and transfer for container closure integrity testing, residual seal force testing, and related assays for cell and gene therapy programmes.

In this role, you will coordinate cross-functional teams, contribute to regulatory submissions, and deliver robust analytical strategies in a collaborative, international environment.

Qualifications

• Independent, accountable and entrepreneurial working style.
• Experience with analytical development in GMP-regulated environments.
• Excellent written and spoken English; German desirable.
• Experience with CCIT/SBIT/RSF or related analytical assays is advantageous.

Responsabilités

• Lead project coordination for CCIT, SBIT and related assays.
• Oversee method development, validation and transfer activities.
• Provide scientific support for investigations and regulatory deliverables.
• Align project plans with partners and stakeholders.
• Prepare technical documents, study reports and validation protocols.
• Contribute to continuous improvement of lab processes and capabilities.

Connaissances

Project coordination

Analytical thinking

Scientific writing

GMP compliance

Regulatory documentation

Instrument biology

Cross-functional collaboration

English proficiency

Formation

Master’s degree +5 years or PhD +2 years in life sciences/analytical development

Description du poste

Cilag AG is seeking a Senior Scientist to lead CCIT and SB IT projects within a GMP- regulated analytical development lab. You will drive method development, validation, and transfer for container closure integrity testing, residual seal force testing, and related assays for cell and gene therapy programmes.

In this role, you will coordinate cross-functional teams, contribute to regulatory submissions, and deliver robust analytical strategies in a collaborative, international environment.