Associate Director - Extractables & Leachables - Technical Development / Associate Directoress - Extractables & Leachables - Technical Development

Job ID

REQ-10085154

Summary

WORK ARRANGEMENT: Onsite, #Onsite
LOCATION: Basel, Switzerland
RELOCATION SUPPORT: This role is based in Basel, Switzerland. Novartis is unable to offer relocation support; please only apply if accessible.

We are seeking a highly skilled and motivated Associate Director to support the local Extractables & Leachables (E&L) Specialty team. In this role, you will contribute to the development and implementation of E&L testing and assessment strategies in alignment with the global E&L community and the wider organization within a multidisciplinary project team focused on developing biological drugs.

About the Role

ROLE PURPOSE
As Associate Director in the Extractables & Leachables (E&L) Specialty CH within Process Analytical Sciences (PAS), you will be part of a dedicated team of over four associates, including laboratory scientists and analytical experts. You will oversee Extractables & Leachables activities primarily related to late-phase assets, focusing on complex and innovative medicines, including Antibody-oligonucleotide conjugates (AOCs) and Cell & Gene Therapy (CGT). This role involves guiding and driving activities within specialty and cross-functional project teams, shaping risk assessments and analytical strategies, and developing concepts in line with internal and external regulatory standards while advancing Data & Digital initiatives within the specialty.

Key Responsibilities

• Provide expert support to a team of over four associates, including laboratory scientists and E&L experts.
• Guide the specialty team in alignment with business priorities and agreed strategies on technical, scientific, and project management matters.
• Act as a Subject Matter Expert (SME) for E&L and lead relevant initiatives within the broader organization.
• Engage with stakeholders and partners (e.g., Drug Substance (DS) and Drug Product (DP) development, Manufacturing Science and Technology (MS&T), toxicologists) to facilitate workflows and satisfy partner needs.
• Coordinate end-to-end project support on relevant E&L activities to ensure submission readiness for projects assigned to the team.
• Ensure compliance with regulatory requirements by applying principles as detailed in relevant guidelines from the Food & Drug Administration (FDA), International Conference on Harmonization (ICH), United States Pharmacopeia (USP), and International Organization for Standardization (ISO).
• Support the integration of Data & Digital tools and Artificial Intelligence (AI) in E&L workflows and lead related initiatives.

Essential Requirements

• A university degree (preferably PhD) in Pharmacy, Biotechnology, Life Sciences, or other relevant science discipline.
• A minimum of 10 years of proven experience in the pharmaceutical industry.
• At least 5 years in a leadership position with a successful performance record in leading teams.
• Advanced knowledge in Extractables & Leachables (including analytics/regulation) as well as biotechnological CMC development.
• Strong leadership skills with the ability to inspire a team of scientists in a dynamic environment.
• Solid business acumen with the capability to align scientific and technical decisions with organizational strategy and priorities.
• Excellent communication and interpersonal skills.
• Strategic thinking, high learning agility, and a solution-oriented mindset.

Commitment to Diversity and Inclusion

Novartis is dedicated to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If you need a reasonable accommodation for any part of the recruitment process because of a medical condition or disability, please email inclusion.switzerland@novartis.com and share the nature of your request along with your contact information. Please include the job requisition number in your message.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you—collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more here.

Benefits and Rewards

Learn about all the ways we will help you thrive personally and professionally. Read our handbook (PDF).

Primary Location Salary Range

CHF 126,000.00 - CHF 234,000.00

Division

Development

Business Unit

Development

Location

Switzerland

Site

Basel (City)

Company / Legal Entity

C028 (FCRS = CH028) Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

Research & Development Development Switzerland

Associate Director - Extractables & Leachables - Technical Development

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Note: Only applications matching the job profile will be considered.