Principal Scientist - Analytical Project Leader

Principal Scientist - Analytical Project Leader

Lonza

Basel, Switzerland

What you will do:

• Lead analytical discussions with customers and interface with Subject Matter Experts (SME) representing all DPS Analytics groups
• Set-up strategy for DPS analytical programs: Control strategy from pre-IND to BLA, specifications, analytical method lifecycle, platform methods/ product-specific methods
• Maintain up-to-date knowledge of assigned molecules, method strategy, industry issues/trends and pharmacopeia as well as adhere to cGMP regulations
• Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing (GMP and non-GMP)
• 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 Managers with technical review analytical SOWs and engage with SMEs as well as amendments team as required
• Contribute to the design and set up of analytical development processes across DPS

What we are looking for:

• Master degree (PhD is a plus) in Biochemistry, Pharmaceutical Sciences, Analytical Science or related field
• At least 5 years of experience working as Analytical and/or QC Project Lead in late clinical phase projects
• Knowledge of analytical lifecycle for biotechnology products, CMC requirements for regulatory filings (IND and BLA)
• Very good knowledge in relevant analytical techniques and protein analytics
• Experience working in analytical development and/or QC preferably with cGMP experience
• Ability to interpret complex analytical data and provide solution with hands on mentality to the Customer
• Excellent communication, reporting and scientific skills
• Fluency in English, written and spoken