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
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