h3Associate Principal Scientist Analytical Project Lead /h3pLonza /ppBasel, Switzerland /ph3What you will do: /h3ulliLead analytical discussions with customers and interface with subject Matter Experts (SME) representing all DPS Analytics groups /liliEnsure project timelines and deliverables are visible and maintained in relevant planning tools /liliOversee delivery of analytical milestones by liaising with relevant DPS Analytics executional groups /liliSupport Project Leads with analytical SOWs and engage with SMEs as well as amendments team as required /liliSet-up strategy for DPS analytical programs: Control strategy, specifications, analytical method lifecycle, platform methods/ product-specific methods /liliMaintain up-to-date knowledge of assigned molecules as well as method strategy, industry issues/trends and pharmacopeia /liliManage 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). /liliContribute to the design and set up of analytical development processes across DPS /liliAdhere to cGMP regulations as required /li /ulh3What we are looking for: /h3ulliPhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field /liliWork experience in analytical development and/or QC, preferably with cGMP experience /liliVery good working knowledge in all relevant analytical techniques /liliExperience with parenteral dosage forms and protein analytics /liliAbility to interpret complex analytical data /liliCapability to work independently and in a team environment /liliExcellent communication, reporting and scientific skills /liliExperience with analytical lifecycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization highly desired /liliExcellent knowledge of written and spoken English /li /ul #J-18808-Ljbffr
