AS&T Senior Specialist

329604BR
Oct 11, 2021
Singapore

Job Description

More than 380! That’s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.
This position will be supporting the consistent planning and implementation of Analytical Science & Technology (AS&T) across the organization to ensure validation and compliance of analytical methods and associated Quality systems with the requirements of the Novartis Quality Manual and all relevant regulatory and legislative requirements.

Key Responsibilities
• Support the assigned projects in the area of analytical method transfer, analytical method validation/verification, to ensure full compliance of introduced analytical methods to current standards. Responsible for implementation of projects into QC laboratories
• Coordinate detailed planning and document deliverables per master plan during analytical method transfer and method validation/verification by working collaboratively within matrix teams with laboratories including QC and MS&T areas
• Provide trending and statistical support for periodic reporting, and or decision making
• Support investigations for major and critical discrepancies (OOS, complaints, deviations). Make recommendation for product quality impact assessments and propose CAPA actions
• Provide support for training, troubleshooting and continuous improvement in the laboratory
• Support audit/inspections, responsible for analytical validation/transfer topics and OOS/investigations
• Other duties assigned by the manager

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Minimum: BS in Pharmacy, Biotechnology, Chemistry, Microbiology or Chemical Engineering
• Desirable: PhD in Biotechnology, Chemistry, or Chemical Engineering
• 8+ years of related experience. Related experience should be in GMP-regulated industries in Quality Control. Experience in analytical development/characterization is a plus
• Must understand FDA/EMA/ICH requirements as well as industry quality systems
• Knowledge and understanding of manufacturing, quality control and development. Experience in bio-technology/bioprocess/bio manufacturing is highly desirable.
• Strong analytical, planning, execution, interpersonal, communication, negotiation and problem solving skills
• Strong project management skills
• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally

Why consider Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Singapore
Singapore
Quality
Full Time
Regular
No
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329604BR

AS&T Senior Specialist

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