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Location: Basel, Switzerland
This role is based in Basel, Switzerland. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.
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
About the Role
Major accountabilities:
- 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, by applying Liquid injection GC/(HR)MS, Headspace-GC/(HR)MSand HPLCLC/(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.
Minimum 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.
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: 93,800.00 -174,200.00 CHF
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. 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. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Read our brochure to learn more about our global total rewards offering:
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
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 a 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.
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. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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