Analytical Expert - ARD (m/f/d)

Location: Basel, Switzerland Role Purpose:We are looking for an Analytical Expert to support Analytical Research & Development (ARD). ARD sits within the Global Technical R&D department of Global Drug Development and plays an essential role in the characterization and analysis of Small Molecule Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to Commercial Production. We are looking for a highly motivated, experienced Analytical Expert with a strong background and experience in parenteral development to join our team.
Expertise in RLT, peptide analytics and parenteral dosage form is required.

Your main responsibilities:
 

• Plan, interpret and report results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).
• Write & review analytical documents (e.g Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and align the corresponding activities within a global project team.
• Drive method development for peptide drug substances and RLT  Drug product.
• Manage interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary.
• Proactively identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.
• Work according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal Novartis guidelines.
• Provide valuable input to the analytical CMC documents and support regulatory submissions.
• Drive, lead, and manage analytical activities including impurity profiling related to the analytical development of RLTs compounds  (e. g. method development, validation, stability, and release testing).
• Provide scientific guidance to the cross-functional and global project teams and thereby scientifically driving our exciting RLT portfolio.
• Display a collaborative and inspired attitude within project teams and  our stakeholders and partners is key.
• Good understanding and awareness of regulatory guidelines for analytical development

What you’ll bring to the role

• PhD in analytical chemistry or equivalent
• At least 5 years experience in the pharmaceutical industry with a track record in GMP activities for development or marketed products.
• Profound expertise in documentation writing (Stability Report, Validation, IND IMPD modules etc)

• Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment.
• Advanced knowledge of laboratory and/or technical tools (e.g. HPLC, LC-MS, Quality management systems, statistical evaluation tools ...)
• Good knowledge of commonly used software and computer tools.
• Excellent  scientific/technical writing skills.
• Eager to develop new methods and assess new analytical techniques.
• Proven leadership in guiding and mentoring colleagues
• Strong coordination skills, collaborative spirit, self-driven attitude, high level of learning agility.
• Strong quality focus  
• Excellent communication and role model skills
• Fluent in English (oral and writing)

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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