347189BR
Jun 15, 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 Senior Expert, Science & Technology will function in an onsite role, where he/she/they will execute analytical testing activities as well as have subject matter expert responsibilities. This role will represent San Diego GMP Analytical testing needs as well as collaborate closely with Analytical Development, Process Analytics, Quality, and other teams to qualify, validate, transfer, and improve analytical methods based on experience, written procedures, and analytical analysis.

Your responsibilities will include, but are not limited to:

• Serves as SME (Subject Matter Experts) in several QC assays, such as AUC (Analytical Ultracentrifugation), cell-based potency, ELISA (Enzyme Linked Immunosorbent Assay), qPCR, and separation assays.
• Plays an active role in establishing the site QC lab operations to support development and commercialization of new gene therapy medicines.
• Routine sample testing under GMP or non-GMP modes (in-process, release, and stability), laboratory maintenance, and participating in method qualification, validation, transfer, and improvement. Reviews and trends results.
• Manages the procurement, implementation, use, and maintenance of equipment, instrumentation, and computer systems.
• Writes and revises documents such as SOPs (Standard Operation Procedures), method validation/transfer protocols, and technical reports.
• Leads investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Identifies and implements innovative technologies to improve the compliance and efficiency of QC operations.
• Represents QC to work with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs.



Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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 and 6 years of industry experience or Associate's degree with 10 years equivalent experience. At least 5 years' experience in GMP Quality Control laboratory preferred.
• Possess strong understanding of QC testing operations and provide expertise in several QC assays, such as AUC, cell-based potency, ELISA, qPCR, and separation assays.
• Ability to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions.
• Ability to work effectively within the group, within Quality, and across sites. Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations, effective interactions/communication with Quality management.
• Highly motivated and solution-driven with ability to succeed in a dynamic and growing Quality Control (QC) team.

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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347189BR

Senior Expert Science & Technology (Analytical Operations)

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