Join to apply for the Senior QC Specialist ( 1 Year Novartis Contract) role at Novartis
Join to apply for the Senior QC Specialist ( 1 Year Novartis Contract) role at Novartis
Summary
We are seeking a motivated analytical expert for biopharmaceutical production within the framework QC testing for in-process controls, raw materials and drug substance. The role involves leading current and future analytical control strategies, focusing on release testing, method validation, and method transfer for new biopharmaceutical entities.
Summary
We are seeking a motivated analytical expert for biopharmaceutical production within the framework QC testing for in-process controls, raw materials and drug substance. The role involves leading current and future analytical control strategies, focusing on release testing, method validation, and method transfer for new biopharmaceutical entities.
About The Role
Major accountabilities:
* Coordinate, review and release of quality control tests on biologics drug substances (Physicochemical testing, e.g. HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements
* Maintain excellent planning and collaboration with project team members (e.g. laboratory analysts, production specialists, manufacturing science and technology, quality assurance, regulatory CMC, project leaders and colleagues)
* Participate in or create, review, approve registration documents
* Manage analytical weak points of assigned pipeline
* Perform deviations/OOX investigation
* Support troubleshooting for testing procedures and make recommendations for improvements, with a focus on HPLC and Capillary Electrophoresis, Bioburden and Endotoxin
* Lead validation and transfer activities for analytical procedures
* Lead qualification, maintenance, and calibration of instruments
* Lead LabOpex Projects
Key Performance Indicators
* Timely completion of key deliverables
* Prompt reporting of missed deadlines and aim for shortest possible lead times
* Consistently follow the GMP and GSU guidelines, and SOPs, ensuring no critical irregularities continuous readiness for inspection
* Proactively identify and implement cost-reducing optimizations
Minimum Requirements
* MSc or PhD in biotechnology, analytical chemistry or related field, +3 years industry experience
* Good IT skills (MS Office) and laboratory software like LIMS, Chromeleon, Empower are an advantage
* Reliability, flexibility, resilience, and strong teamwork skills
Skills
* Continuous learning
* Dealing with ambiguity
* Decision making
* GMP
* Industry standards
* Laboratory equipment
* Laboratory excellence
* Quality Control (QC) testing
* Quality Control sampling
* Self awareness
* Technological expertise
Languages
* Fluent in English and German (spoken and written)
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
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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