Senior Expert Extractables & Leachables

Novartis Pharma Schweiz AG seeks a Senior Expert in Extractables & Leachables in Basel to lead E&L projects, ensure regulatory compliance, and support end-to-end drug development.

The company is looking for a specialist to drive extractables and leachables (E&L) initiatives within Process Analytical Sciences. This role involves managing project activities, serving as the primary subject matter expert, and ensuring that drug development processes align with evolving regulatory standards.

Responsibilities

• Oversee and coordinate E&L project activities, including conducting risk assessments.
• Serve as the single point of contact and subject matter expert for assigned projects.
• Execute full-cycle E&L studies for container closure systems, manufacturing materials, and administration components.
• Analyze, interpret, and consolidate analytical results to draw meaningful conclusions.
• Draft and review E&L protocols, reports, and assessments.
• Assist in addressing Health Authority Queries (HAQs).
• Stay updated on the latest regulatory requirements to maintain knowledge alignment.
• Lead cross-functional initiatives relevant to the local or global E&L community.

Requirements

• University degree, preferably a PhD, in Pharmacy, Polymer Science, Food Chemistry, Life Sciences, or a related scientific field.
• At least 8 years of professional experience, ideally within the pharmaceutical or biopharmaceutical industry.
• Proficiency in at least one analytical technology: Headspace-GC/MS, LIGC/(HR)MS, HPLC/(HR)MS, or related sample preparation methods.
• Strong scientific writing capabilities.
• Demonstrated project management expertise.
• Excellent communication and collaboration skills.
• Proven track record of leading local or global initiatives.

What the company offers

• Performance-based bonus tied to specific performance metrics.
• Comprehensive insurance plans, retirement benefits, wellbeing resources, and global recognition programs.
• Flexible and hybrid working arrangements where feasible.
• Minimum 14 weeks of paid parental leave.

About the company

Novartis Pharma Schweiz AG fosters a culture defined by agility, curiosity, a product mindset, and a forward-thinking attitude.

• Agility
• Curiosity
• Product mindset
• Forward-thinking attitude