Du führst analytische Diskussionen mit Kunden und setzt Strategien für analytische Programme auf, während du auch die Entwicklung neuer Methoden leitest.
Anforderungen
- •Master degree in Biochemistry or related field
- •At least 5 years of experience as Analytical Project Lead
- •Proven knowledge of analytical lifecycle and CMC requirements
- •Very good knowledge in analytical techniques and protein analytics
- •Experience in analytical development and/or QC with cGMP
- •Ability to interpret complex analytical data
- •Excellent communication and scientific skills
Deine Aufgaben
- •Führe analytische Diskussionen mit Kunden
- •Setze Strategie für DPS analytische Programme auf
- •Halte Wissen über Moleküle und Methodstrategien aktuell
- •Leite Entwicklung und Bewertung analytischer Methoden
- •Sichere Projektzeitpläne und Sichtbarkeit der Ergebnisse
- •Unterstütze Projektmanager bei technischen Überprüfungen
Original Beschreibung
# Analytical Project Leader – Principal Scientist (f/m/d)
**CH - Basel** | **Full time**
The actual location of this job is in Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, we have an outstanding opportunity within the Analytical Project Leadership team. Are you ready to become part of a dynamic group that supports Customers in the development of their CMC strategy and enables them overcoming some of the greatest challenges required to bring therapies to life?
## Key responsibilities:
* Lead analytical discussions with customers and collaborate with Subject Matter Experts (SME) representing all Analytics groups across the Lonza network including DS and DP sites
* Set-up strategy for DPS analytical programs: Control strategy from pre-IND to BLA (QbD, ATP, QTPP, CQA assessment, ATA), specifications and justifications for specifications, analytical method lifecycle (monitoring of performances of platform methods and 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
* Lead development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing
* Ensure project timelines and deliverables are visible and maintained in relevant planning tools
* Support Project Managers with technical review analytical SOWs and engage with SMEs as well as amendments team as required
## Key requirements:
* 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
* Proven 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
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.