Location: Basel, Switzerland. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Role Overview
As a Senior Expert in Extractables & Leachables (E&L) within Process Analytical Sciences (PAS), you will lead and manage E&L related project activities, applying scientific expertise across a wide range of E&L relevant fields (e.g. Analytics, Polymer and Materials Science, Drug Product/Drug Substance manufacturing). In this hybrid role you will manage operational aspects in close collaboration with internal laboratory teams or external partners, within a multidisciplinary project team. You will also contribute to or lead initiatives aimed at adapting workflows, E&L testing and risk assessment strategies supporting end‑to‑end drug development in an evolving portfolio and regulatory context. Major Accountabilities
Design, supervise and coordinate E&L related project activities (incl. risk assessments) for assigned projects. Act as SPOC and SME for assigned projects. Run end‑to‑end E&L studies for container closure systems, manufacturing and administration materials, applying Liquid Injection GC/(HR)MS, Headspace‑GC/(HR)MS and HPLC‑(HR)MS and other relevant techniques as appropriate, with support of internal labs or external partners (CROs). Evaluate, interpret and consolidate results of analyses and draw relevant conclusions (e.g. E&L correlations, consistency of findings vs. tested materials). Author and review E&L protocols, reports and assessments intended for internal and external partners and support the preparation of IND/BLA relevant sections as appropriate. Support on responses to HAQs as appropriate. Communicate, address and solve complex problems within own area of responsibility. Ensure effective collaboration with all stakeholders through management of interfaces across functions. Actively drive knowledge sharing, present scientific results internally and actively contribute to Novartis relevant networks and workstreams. Ensure continuous alignment of own knowledge with the latest regulatory requirements. Lead initiatives relevant for the local or global E&L community requiring cross‑functional collaboration aiming at adapting ways of working, documentation, testing or assessment strategies. Qualifications
University degree (preferably PhD) in Pharmacy, Polymer or Food Chemistry, Life Sciences or another relevant science discipline. 8+ years of working experience, preferably in the pharma/biopharmaceutical industry or another relevant industry. Expertise in at least one of the following analytical technologies: Headspace‑GC/MS, Liquid Injection GC/(HR)MS, HPLC/(HR)MS, and related sample preparation techniques. Excellent scientific writing skills. Strong project management skills. Excellent communication and collaboration skills. Proven ability to lead local or global initiatives. Agility, curiosity, product mindset and forward‑thinking attitude. Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together and rewarding the people who make it happen. The expected annual base salary range for this role is CHF 93,800.00 – 174,200.00, determined by gender‑neutral objectives such as relevant skills, competencies and experience. A performance‑based bonus may also be offered. In addition to your base salary, you may be eligible for a range of competitive benefits in kind to help you thrive personally and professionally, including insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf. Accessibility and Accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need reasonable accommodation for any part of the recruitment process, or to receive more detailed information about the essential functions of this position, please send an e‑mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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As a Senior Expert in Extractables & Leachables (E&L) within Process Analytical Sciences (PAS), you will lead and manage E&L related project activities, applying scientific expertise across a wide range of E&L relevant fields (e.g. Analytics, Polymer and Materials Science, Drug Product/Drug Substance manufacturing). In this hybrid role you will manage operational aspects in close collaboration with internal laboratory teams or external partners, within a multidisciplinary project team. You will also contribute to or lead initiatives aimed at adapting workflows, E&L testing and risk assessment strategies supporting end‑to‑end drug development in an evolving portfolio and regulatory context. Major Accountabilities
Design, supervise and coordinate E&L related project activities (incl. risk assessments) for assigned projects. Act as SPOC and SME for assigned projects. Run end‑to‑end E&L studies for container closure systems, manufacturing and administration materials, applying Liquid Injection GC/(HR)MS, Headspace‑GC/(HR)MS and HPLC‑(HR)MS and other relevant techniques as appropriate, with support of internal labs or external partners (CROs). Evaluate, interpret and consolidate results of analyses and draw relevant conclusions (e.g. E&L correlations, consistency of findings vs. tested materials). Author and review E&L protocols, reports and assessments intended for internal and external partners and support the preparation of IND/BLA relevant sections as appropriate. Support on responses to HAQs as appropriate. Communicate, address and solve complex problems within own area of responsibility. Ensure effective collaboration with all stakeholders through management of interfaces across functions. Actively drive knowledge sharing, present scientific results internally and actively contribute to Novartis relevant networks and workstreams. Ensure continuous alignment of own knowledge with the latest regulatory requirements. Lead initiatives relevant for the local or global E&L community requiring cross‑functional collaboration aiming at adapting ways of working, documentation, testing or assessment strategies. Qualifications
University degree (preferably PhD) in Pharmacy, Polymer or Food Chemistry, Life Sciences or another relevant science discipline. 8+ years of working experience, preferably in the pharma/biopharmaceutical industry or another relevant industry. Expertise in at least one of the following analytical technologies: Headspace‑GC/MS, Liquid Injection GC/(HR)MS, HPLC/(HR)MS, and related sample preparation techniques. Excellent scientific writing skills. Strong project management skills. Excellent communication and collaboration skills. Proven ability to lead local or global initiatives. Agility, curiosity, product mindset and forward‑thinking attitude. Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together and rewarding the people who make it happen. The expected annual base salary range for this role is CHF 93,800.00 – 174,200.00, determined by gender‑neutral objectives such as relevant skills, competencies and experience. A performance‑based bonus may also be offered. In addition to your base salary, you may be eligible for a range of competitive benefits in kind to help you thrive personally and professionally, including insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf. Accessibility and Accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need reasonable accommodation for any part of the recruitment process, or to receive more detailed information about the essential functions of this position, please send an e‑mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Senior Expert Extractables & Leachables Arbeitgeber: Novartis Farmacéutica
Novartis Farmacéutica ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Basel, Schweiz, eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf Innovation und Zusammenarbeit fördert das Unternehmen die persönliche und berufliche Weiterentwicklung seiner Mitarbeiter durch umfassende Schulungsprogramme und spannende Projekte im Bereich Life Sciences und KI. Die attraktiven Vergütungen und umfangreichen Sozialleistungen machen Novartis zu einem idealen Ort für Fachkräfte, die einen bedeutenden Beitrag zur Gesundheitsversorgung leisten möchten.
