Senior Expert Analytical Science (m/f/d) at Novartis

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

174200.0

Posted On

06 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oligonucleotide Analytics, Analytical Method Development, Validation, Stability Testing, HPLC, UV-Spectroscopy, Titration, Mass Spectrometry, GMP, GLP, CMC Documentation, Technical Writing, Laboratory Management, OOS Investigations, CAPA, Regulatory Submissions

Industry

Pharmaceutical Manufacturing

Description

Salary Range: CHF93,800.00 - CHF174,200.00 Job Description 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. Job Description 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. Skills Desired Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

Design and execute analytical activities for Oligonucleotide drug substances and products, including method development and validation. Provide technical leadership, mentorship to associates, and support regulatory submissions through CMC documentation.