345630BR
May 19, 2022
USA

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Associate Expert Science and Technology will be an integral team member of the Analytical Operations department located at the Novartis Gene Therapies San Diego R&D facility. He/She/They will play a vital role in supporting routine and non-routine testing of novel gene therapy products, qualifying, validating, and transferring analytical methods, and supporting internal partners in Analytical Development and Process Sciences in ensuring robust methods are in place to characterize these therapies.

Your responsibilities will include, but are not limited to:

• Performs routine sample testing, and review, under GMP or non-GMP modes, laboratory maintenance, participating in method qualification/validations.
• Supports investigations and write and revise SOPs and other technical reports and documents.
• Performs established analytical methods such as PCR, immunoassays, chromatography, AUC, and electrophoresis to support QC operations.
• Participates in assay troubleshooting, qualification and validation if needed.
• Manages the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems.
• Supports investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Participates in the generation and review of CofA/CofT for batch release.
• Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you'll bring to the role:

• Bachelor's degree in Chemistry, Biology or related scientific field.
• 2 years GMP lab experience within the Biotechnology/Pharmaceutical Industry
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.
• Proficient in Microsoft Word, Excel, Power Point and other applications such as, common laboratory software such as Empower 3, Quantasoft, etc.
• Knowledge of GLP and GDP principles required.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.


Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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 here at Novartis!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.


Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Global Drug Development
TECHNICAL R & D GDD
USA
San Diego, CA
Quality
Full Time
Regular
No
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345630BR

Associate Expert, Science & Technology (QC Analyst/Sr Analyst)

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