Analytical Project Leader

Vor 6 Tagen

Basel, Basel-Stadt, Schweiz Lonza Vollzeit

About Lonza

Lonza is a global leader in life sciences, operating across three continents. Our success is built on the expertise of talented individuals working together to develop innovative solutions that improve people's lives.

Our Mission

We strive to be a trusted partner for businesses, helping them to overcome complex challenges and bring therapies to life. Our commitment to excellence is reflected in our rigorous approach to quality and our dedication to protecting the environment and our people.

The Role

We are seeking an experienced Analytical Project Leader to join our dynamic team in Basel, Switzerland. As a key member of our Analytical Project Leadership team, you will play a critical role in supporting our customers in the development of their CMC strategy and enabling them to overcome the greatest challenges in bringing therapies to life.

Key Responsibilities

  • Lead analytical discussions with customers and interface with Subject Matter Experts (SMEs) representing all DPS Analytics groups.
  • Set up strategy for DPS analytical programs, including product control strategy, specifications, analytical method lifecycle, platform methods, and product-specific methods.
  • Maintain up-to-date knowledge of assigned molecules, method strategy, industry issues and trends, and pharmacopeia, as well as adhere to cGMP regulations.
  • Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing (GMP and non-GMP).
  • 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 Managers with the technical review of the analytical SOWs and engage with SMEs as well as amendments teams as required.

Key Requirements

  • University degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field (PhD is a plus).
  • Very good knowledge in protein analytics, all relevant analytical techniques, and parenteral dosage forms.
  • Ability to interpret complex analytical data.
  • Experience working in analytical development and/or QC, preferably with cGMP experience.
  • Knowledge of analytical lifecycle for biotechnology products, CMC requirements for regulatory filings, and working in a matrix organization highly desired.
  • Excellent communication and scientific skills.
  • Solution-oriented mindset.
  • Fluency in English, written and spoken.

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