摘要
About the Role
Key Responsibilities:
- Lead analytical method transfer, method validation/verification activities, ensuring full compliance of introduced analytical methods to current standards.
- Act as subject matter expert for analytical and bio-analytical methods for testing of biopharmaceutical molecules (HPLC, UPLC, CIEF, Capillary Electrophoresis, PCR, ELISA, etc)
- Support onsite investigations related to OOX and deviations.
- Customer management and new product introduction to the site.
- Improvements in Analytical Methods and life cycle management.
- Introduction of new technologies for analytical testing.
- APQR, OPV analytics section authoring, and perform assessments.
- Stability Study Design, Protocol, and report preparation. Awareness of ICH requirements.
- Basic knowledge of Statistical data evaluation and trend assessment.
- Regulatory dossier reviews for analytical methods, method validation, stability, and control of materials.
- Third-party testing lab management- Track deliverables and provide technical guidance as per company policy.
- Raw material assessment for new product introduction and pharmacopeia compliance evaluation.
Essential Requirement
- BS degree with 8+ years of pharmaceutical/biotechnology analytics industry experience
- MS degree with 4+ years of pharmaceutical/biotechnology analytics industry experience
- Working experience in Laboratory environment in the biopharmaceutical analytics/QC/ equivalent industry.
- Familiar with major pharmacopeia standards such as USP, EP, JP/JPE, ChP etc
- Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities
- Must have a working knowledge of health authority and regulatory requirements as well as industry quality management tools, standards, and quality systems.
- Working experience in GMP-regulated industries in the Quality Control analytics department is an advantage.
- Willing to travel from time to time from Malaysia to Singapore.
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
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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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
