Senior Expert Extractables & Leachables

Novartis seeks a Senior Expert in Extractables & Leachables to lead E&L projects, manage studies, and support drug development in Basel.

The company is looking for a specialist to oversee Extractables & Leachables initiatives within Process Analytical Sciences. This role involves guiding project workflows, conducting risk assessments, and adapting testing strategies to support the full drug development lifecycle.

Responsibilities

• Direct and coordinate Extractables & Leachables projects, including risk assessments.
• Serve as the primary point of contact and subject matter expert for assigned initiatives.
• Conduct comprehensive E&L studies for container closure systems and manufacturing materials.
• Analyze, interpret, and consolidate analytical results to draw meaningful conclusions.
• Draft and review E&L protocols, reports, and assessments.
• Assist in preparing sections relevant to IND/BLA submissions.
• Help address Health Authority Queries (HAQs).
• Stay updated on the latest regulatory requirements.
• Lead cross-functional initiatives for the local or global E&L community.

Requirements

• University degree, preferably a PhD, in Pharmacy, Polymer, Food Chemistry, Life Sciences, or a related field.
• At least 8 years of experience, ideally in the pharma or biopharmaceutical sector.
• Proficiency in analytical technologies such as Headspace-GC/MS, LIGC/(HR)MS, HPLC/(HR)MS, and sample preparation.
• Strong scientific writing abilities.
• Proven project management capabilities.
• Experience managing small teams.

What the company offers

• Performance-based bonus tied to specific parameters.
• Insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options, where possible.
• Minimum 14 weeks paid parental leave.

About the company

Novartis is committed to reimagining medicine together.

• Novartis is committed to reimagining medicine together.