Senior Expert Extractables & Leachables

Role

Full-time

Permanent

Senior

Science & Research

Logistics

Basel (City)

Hybrid

Expected Annual Base Salary Range for role: 93,800.00 -174,200.00 CHF

Closes in 30 days

Requirements

8+ yrs exp

PhD

EU/EFTA permit

Skills

PharmacyData AnalysisLife SciencesCollaborationLiquid injection GC/(HR)MSExtractables & Leachables (E&L)Polymer scienceScientific Publication WritingIT Risk AssessmentGlobal Project ManagementDocumentationCompliance

Compensation

Expected Annual Base Salary Range for role: 93,800.00 -174,200.00 CHF

Description

As Senior Expert in the field of Extractables & Leachables (E&L) within Process Analytical Sciences (PAS), you will lead and manage E&L related project activities, applying your 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 role, you will manage operational aspects in close collaboration with internal lab(s) or external partners, within a multidisciplinary project team. You will also contribute to, or lead, initiatives aiming at adapting workflows, E&L testing and risk assessment strategies supporting end-to-end drug development in a context of evolving portfolio and strongly evolving E&L Regulation.

Responsibilities

Design, supervise and coordinate E&L related projects 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.
Evaluate, interpret and consolidate results of analyses and draw relevant conclusions.
Author and review E&L protocols, reports and assessments intended for internal and external partners.
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.

Requirements

University degree (preferably PhD) in Pharmacy, Polymer or Food Chemistry, Life Sciences or other relevant science discipline.
8+ years of working experience, preferably in pharma/biopharmaceutical industry or other relevant industry.
Expertise in at least one of the following analytical technologies: Headspace-GC/MS, LIGC/(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.

Tech stack

Liquid injection GC/(HR)MSHeadspace-GC/(HR)MSHPLCLC/(HR)MS

Benefits

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
We provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Company

Novartis

Pharmaceuticals

Contact

diversity.inclusion_ch@novartis.com