Senior Analytical Project Lead - Method Development & GMP

Lonza Group Ltd.; Basel; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza Group Ltd. in Basel seeks a senior analytical chemist to lead discussions with customers and SMEs across the DPS Analytics groups. You will ensure milestones are tracked in planning tools and oversee timely delivery of analytics projects and SOWs.

A strong background in analytical method development within GMP contexts is essential. You will shape strategies for analytical programs, maintain molecule knowledge, and drive regulatory-ready data packages while collaborating across matrix

Qualifikationen

• PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• Work experience in analytical development and/or QC, preferably with cGMP experience.
• Very good working knowledge in all relevant analytical techniques.
• Experience with parenteral dosage forms and protein analytics.
• Ability to interpret complex analytical data.
• Capability to work independently and in a team environment.
• Excellent communication, reporting and scientific skills.
• Experience with analytical lifecycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization highly desired.
• Excellent knowledge of written and spoken English.

Aufgaben

• Lead analytical discussions with customers and interface with SMEs across DPS Analytics groups
• Ensure project timelines and deliverables are visible and maintained in planning tools
• Oversee delivery of analytical milestones by liaising with DPS Analytics execution groups
• Support Project Leads with analytical SOWs and engage with SMEs and amendments team
• Set up strategy for DPS analytical programs: control strategy, specs, lifecycle, platform methods
• Maintain knowledge of molecules and method strategy, industry trends
• Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing
• Adhere to cGMP regulations as required

Kenntnisse

Analytical chemistry

Biochemistry

cGMP experience

Data interpretation

Team collaboration

English proficiency

Ausbildung

PhD in Analytical Chemistry

Tools

HPLC

CE

UV-Vis

pH measurement

Osmolality

Visual inspection

Jobbeschreibung

Lonza Group Ltd. in Basel seeks a senior analytical chemist to lead discussions with customers and SMEs across the DPS Analytics groups. You will ensure milestones are tracked in planning tools and oversee timely delivery of analytics projects and SOWs.

A strong background in analytical method development within GMP contexts is essential. You will shape strategies for analytical programs, maintain molecule knowledge, and drive regulatory-ready data packages while collaborating across matrix