Associate Principal Scientist Analytical Project Lead

Lonza

Basel, Switzerland

• 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

• 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