Job Title: Senior Method Expert, Process Analytical Sciences
Company: Novartis
Location: Basel, Switzerland
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular
Role Purpose
Join the Novartis Process Analytical Sciences team in Basel, Switzerland, and bring your expertise in analytical method development to contribute to the development of biologics drug substances and products. This role focuses on applying Quality-by-Design (QbD) principles to create robust and reliable analytical methods, leveraging advanced instrumentation, miniaturization, and automation to enhance efficiency and throughput.
Key Responsibilities
Method Development and Optimization:
Apply QbD principles to drive physicochemical analytical (PCA) method development and optimization for drug substances, drug products, and intermediates.
Design experiments, perform risk assessments, and use statistical tools to develop reliable and scalable methods.
Ensure method performance is tracked through control charts and trending.
Advanced Instrumentation and Technology:
Utilize advanced analytical tools (e.g., HPLC/UPLC, CE, cIEF) and emerging technologies to improve existing methods.
Explore opportunities for miniaturization and automation to increase throughput and efficiency.
Data-Driven Method Development:
Employ data analytics, machine learning, and modeling approaches to correlate product quality attributes with method parameters and optimize methods.
Regulatory Compliance:
Ensure compliance with regulatory guidelines (e.g., ICH Q2(R2), Q14) for analytical method development, and stay updated on evolving requirements.
Collaboration and Leadership:
Work closely with cross-functional teams (e.g., process development, quality assurance, regulatory affairs) to align method development activities with project timelines.
Provide leadership, guidance, and mentorship to junior team members.
Qualifications
Experience:
Senior expertise in analytical method development using QbD principles, automation, and data-driven approaches.
Minimum of 10 years of experience in the pharmaceutical industry, particularly in biotechnological CMC development.
Hands-on experience with state-of-the-art analytical instrumentation (HPLC/UPLC, CE, cIEF).
Solid understanding of pharmaceutical development, analytical sciences, and regulatory compliance.
Education:
A university degree in life sciences (PhD or equivalent is desirable).
Skills:
Ability to influence without authority and work effectively in a matrixed environment.
Strong scientific and technical knowledge, with expertise in automation and data/digital approaches.
Why Novartis?
At Novartis, we are committed to reimagining medicine and improving the lives of patients globally. This is a great opportunity to contribute to groundbreaking work in biologics drug development in a vibrant and innovative environment.
Commitment to Diversity & Inclusion
Novartis fosters an inclusive work environment with diverse teams that reflect the communities we serve.
Benefits and Rewards
Novartis offers comprehensive benefits to support both personal and professional growth. Learn more here.
Join the Novartis Network
If this role isn’t the right fit, join our talent community to stay informed about future opportunities here.
For more details or to apply, visit Novartis Careers.
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