Senior Method Expert
vor 4 Wochen
SummaryAre you experienced in Analytical Method Development? Have you successfully created analytical methods based on QbD Principles for both manual and automated sample preparation? Have you worked with automated solutions for method development? Do you enjoy tackling challenges and innovating new physicochemical methods for biopharmaceutical molecules? Are you interested in living in a lively region of Europe with abundant cultural and outdoor activities? If you answered affirmatively to these questions, we invite you to join the Novartis Process Analytical Sciences team in Basel, Switzerland. Our team focuses on developing Biologics drug substances and products, leveraging agility, innovation, and scalability to best serve our portfolio, partners, and patients.
About the Role
Your main responsibilities
As an experienced Method Expert, you will be a key member of the Method Expert Team within Process Analytical Sciences at our TRD Biologics site in Basel.
Your duties include, but are not limited to:
- Method Development and Optimization using Quality-by-Design (QbD) Principles: Drive and execute physicochemical analytical (PCA) method development and optimization for assigned pipeline projects utilizing QbD principles. Design experiments, conduct risk assessments, and employ statistical tools to establish robust analytical methods.
- Method trending: Ensure proper trending of method performance parameters by setting up trend/control charts for relevant methods.
- Advanced Instrumentation and Technology: Make use of advanced analytical instrumentation and emerging technologies to enhance current analytical methods.
- Miniaturization and Automation: Explore options for miniaturization and automation to boost efficiency, reduce sample and reagent usage, and enhance throughput. Implement automated platforms for streamlined method development.
- Data-Driven Approaches: Utilize data analytics, machine learning, and artificial intelligence to analyze large datasets and develop data-driven approaches for method development. Identify critical quality attributes, process parameters, and correlations to optimize method performance.
- Regulatory Compliance: Ensure adherence to regulatory requirements and aid in filings by applying principles outlined in current guidelines for analytical method development (e.g., ICH Q2(R2) and Q14). Stay informed about evolving regulatory expectations and validation strategies.
- Collaboration and Leadership: Collaborate with diverse teams, such as research, DS & DP process development, quality assurance, and regulatory affairs, to align method development activities with organizational objectives and project timelines. Provide technical leadership, guidance, and mentorship to junior team members.
Your qualifications for the role
- Hands-on experience with state-of-the-art analytical instrumentation (HPLC/UPLC, CE, cIEF)
- Extensive expertise in physicochemical analytical method development
- Proficiency in applying QbD principles
- Strong background in automation and data & digital
- Solid technical and scientific knowledge of pharmaceutical development, analytical sciences, or equivalent
- Significant experience in biotechnological CMC development
- Ability to work effectively in a matrix environment
- Capability to influence without having formal authority
Preferred qualifications
- University degree (PhD or equivalent is preferred) in life sciences
- Minimum of 10 years of proven experience in the pharmaceutical industry
Why choose to work at Novartis? Our mission is to rethink medicine to enhance and prolong people's lives, aiming to be the most valued and trusted pharmaceutical company globally. How do we intend to achieve this? Through our people. It's our team members who inspire us daily to reach our aspirations. Be part of this journey and join us.
What you'll get: You can find comprehensive information on our benefits and rewards in the Novartis Life Handbook.
Dedication to Diversity and Inclusion: Novartis is dedicated to establishing an exceptional, inclusive work environment and diverse teams that reflect the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to collaborating with and providing reasonable accommodation to all individuals. If you require a reasonable accommodation due to a medical condition or disability during any part of the recruitment process, please reach out to us.
Join our Novartis Network: If this position doesn't align with your current experience or career objectives but you want to stay informed about Novartis and future career opportunities, become part of the Novartis Network.
Why choose Novartis: Assisting individuals with illnesses and their families demands more than just innovative science. It requires a community of intelligent, dedicated individuals like yourself collaborating, supporting, and inspiring each other to achieve breakthroughs that transform patients' lives. Ready to build a brighter future together?
Join our Novartis Network: If this Novartis role isn't the right fit for you, sign up for our talent community to stay connected and be informed about suitable career prospects as they arise.
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