摘要
Role Purpose:
Are you skilled in Analytical Method Development? Have you developed analytical methods based on QbD Principles for both, human and automated sample preparation? Have you used automated solutions for method development? Do you thrive on challenges and enjoy creating new physicochemical methods for biopharmaceutical molecules? Would you be willing to mentor and support your colleagues in their professional growth? Are you attracted to living in a vibrant region of Europe with abundant cultural and outdoor activities?
If your answer is "yes" to these questions, then we want you to join the Novartis Process Analytical Sciences team in Basel, Switzerland.
Our team develops Biologics drug substance and drug products, from candidate selection to launch, emphasizing agility, innovation, and scalability to best serve our portfolio, partners, and patients.
About the Role
Your key responsibilities
As Senior Method Expert you will be part of the Method Expert Team of Process Analytical Sciences at our TRD Biologics site in Basel.
Your responsibilities include, but are not limited to:
Method Development and Optimization using Quality-by-Design (QbD) Principles: Applying QbD principles, drive and execute the physicochemical analytical (PCA) method development and optimization of assigned pipeline projects for all relevant sample matrices (Drug Substance, Drug Product, Intermediates). Design experiments, perform risk assessments, and utilize statistical tools to develop robust and reliable analytical methods. Method trending: Ensure appropriate trending of method performance parameters by establishing trend/control charts for relevant methods. Advanced Instrumentation and Technology: Leverage advanced analytical instrumentation and emerging technologies to enhance existing analytical methods. Miniaturization and Automation: Explore opportunities for miniaturization and automation to increase throughput, reduce sample and reagent consumption, and enhance efficiency. Implement automated platforms to streamline method development. Data-Driven Approaches: Utilize data analytics, machine learning and modelling approaches for method development. Identify correlations between product quality attributes and method parameters to optimize method performance. Regulatory Compliance: Ensure compliance with regulatory requirements and support filings applying principles described in recent guidelines for analytical method development (e.g. ICH Q2(R2) and Q14). Stay updated on evolving regulatory expectations e.g. related to validation strategies. Collaboration and Leadership: Collaborate with cross-functional teams, including research, DS & DP process development, quality assurance, and regulatory affairs, to align method development activities with organizational goals and project timelines. Provide technical leadership, guidance, and mentorship to junior team members.
What you’ll bring to the role
- Hands-on experience with state-of-the-art analytical instrumentation (HPLC/UPLC, CE, cIEF)
- Senior expertise in physicochemical analytical method development
- Senior expertise in applying QbD principles
- Expertise in automation and data & digital
- Sound technical and scientific knowledge of pharmaceutical development, analytical sciences, or equivalent
- Experience in biotechnological CMC development
- Ability to work in a matrix environment
- Influencing without authority
Desirable requirements
• University degree (PhD or equivalent is desirable) in life sciences
• Minimum of 10 years of proven relevant experience in the pharmaceutical industry
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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 a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] 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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
