Senior Expert Analytical Science (m/f/d)

Summary

Location: Basel, Switzerland #onsite

Role Purpose:
We are seeking a highly motivated Senior Expert Analytical Scientist with experience in Oligonucleotides analytics to join our Analytical Research & Development (ARD) team. ARD is part of the Technical R&D Department within Development and plays a pivotal role in the characterization and analysis of Drug Substances and Drug Products throughout the transition from discovery to commercial production.

About the Role

Major accountabilities:

• Independently design, plan, execute, interpret, and report analytical activities for Oligonucleotides (DS and DP) utilizing cutting-edge analytical sciences and technologies (such as analytical method development, validation, transfer, stability, release testing, and formulation development analytics) in accordance with established timelines and quality standards. This position requires active participation in laboratory operations.
• Proactively identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.
• Foster and share best practices, provide robust scientific and technical expertise within the analytical project team, among analytical scientists, and throughout the organization.
• Create analytical documents that align with global project strategies by phase. Assist in strategic planning, design, and execution. Write & review analytical documents (e.g analytical methods, specifications, validation reports, stability report, batch records for stability and release testing) and align the corresponding activities within the project team.
• Participate to the planning and implementation of laboratory experiments for designated projects, including activity scheduling, experiment monitoring, and data analysis.
• Offer scientific guidance and mentorship to laboratory associates.
• Oversee technical analytical deviations, investigations of OOS, OOE, OOT. Recommend appropriate corrective and preventive actions (CAPAs).
• Provide valuable input to the analytical CMC documents and support regulatory submissions.
• Assist with audits and health authority inspections, making sure there are no major findings in the areas assigned.
• Follow SOPs, GMP, GLP, QM, HSE, ISRM, and Novartis Guidelines.
• Demonstrate excellent collaboration and encourage sharing of expertise.

Minimum Requirements:

• PhD with a minimum of 3 years’s experience or Master degree in analytical chemistry with a minimum of 10 years’ experience in the pharmaceutical industry.
• Strong experience in Oligonucleotide analytics is required; Experience in Antibody-Oligonucleotide conjugates is an asset.
• Excellent knowledge of laboratory management and analytical techniques. , e.g. HPLC, UV-spectroscopy, titration. Experience in mass spectrometry applied to Oligonucleotide therapeutics is an asset.
• Profound expertise in scientific and technical documentation writing, e.g. reports for method development, stability studies, validation and IND IMPD modules.
• Proven experience in quality principles driving drug development such as GMP; understanding of general regulatory and quality expectations.
• Ability to perform in a highly dynamic environment
• Key qualities include strong coordination, clear communication, teamwork, self-motivation, and quick learning.
• Fluent in English (oral and written)

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 : CHF 93,800 to CHF 174,200

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.

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?

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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