Analytical Project Leader - Principal Scientist
Analytical Project Leader - Principal Scientist
Lonza
Basel, Switzerland
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? Apply now!
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
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