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
Associate Principal Scientist Analytical Project Lead in Basel Arbeitgeber: Lonza
Lonza ist ein hervorragender Arbeitgeber, der eine dynamische Arbeitskultur und flexible Arbeitsmöglichkeiten bietet, um die besten Talente zu fördern. Mit einem starken Fokus auf persönliche Entwicklung und Teamarbeit ermöglicht Lonza seinen Mitarbeitern, ihre Karriere in einem bedeutenden Bereich wie der internen Revision voranzutreiben, während sie gleichzeitig zur Verbesserung von Millionen von Leben beitragen. Die enge Zusammenarbeit vor Ort fördert nicht nur den Austausch von Ideen, sondern auch die technische Präzision, die für die Herstellung von Arzneimitteln erforderlich ist.
