Associate Principal Scientist Analytical Project Lead

1000scholars; Basel; Vor Ort; CHF 140.000 - 200.000; Vollzeit

Zusammenfassung

Lonza in Basel, Switzerland, seeks an Associate Principal Scientist Analytical Project Lead to drive analytical strategy and execution for GMP and non-GMP programs. You will lead customer discussions, coordinate SMEs, and ensure milestones are met through robust project planning and cross-functional collaboration.

The role requires a PhD, strong knowledge of analytical techniques, and experience with protein analytics and regulatory expectations.

Qualifikationen

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field.

Aufgaben

• Lead analytical discussions with customers and interface with SMEs representing DPS Analytics groups.
• Ensure project timelines and deliverables are visible and maintained in relevant planning tools.
• Oversee delivery of analytical milestones by liaising with relevant DPS Analytics executional groups.
• Support Project Leads with analytical SOWs and engage with SMEs and amendments team as required.
• Set-up strategy for DPS analytical programs: Control strategy, specifications, analytical method lifecycle, platform methods/ product-specific methods.
• Maintain up-to-date knowledge of assigned molecules, method strategy, and industry trends.
• Manage development and evaluation of analytical methods to support formulation development and Drug Product testing (GMP and non-GMP, including HPLC and CE purity methods).
• Adhere to cGMP regulations as required.

Kenntnisse

Analytical development

cGMP experience

Analytical techniques

Protein analytics

Data interpretation

Independent work

Communication skills

English proficiency

Ausbildung

PhD in Analytical Chemistry or related field

Tools

HPLC

CE

UV methods

Jobbeschreibung

Associate Principal Scientist Analytical Project Lead

Lonza

Basel, Switzerland

What you will do:

• Lead analytical discussions with customers and interface with subject Matter Experts (SME) representing all DPS Analytics groups
• Ensure project timelines and deliverables are visible and maintained in relevant planning tools
• Oversee delivery of analytical milestones by liaising with relevant DPS Analytics executional groups
• Support Project Leads with analytical SOWs and engage with SMEs as well as amendments team as required
• Set-up strategy for DPS analytical programs: Control strategy, specifications, analytical method lifecycle, platform methods/ product-specific methods
• Maintain up-to-date knowledge of assigned molecules as well as method strategy, industry issues/trends and pharmacopeia
• Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing (GMP and non-GMP, specifically including HPLC and CE purity methods, content by UV, color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visual inspection).
• Contribute to the design and set up of analytical development processes across DPS
• Adhere to cGMP regulations as required

What we are looking for:

• 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