348279BR
Jul 06, 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.

Under general direction, the Expert (Scientist) Science & Technology will perform bioanalytical testing and other activities and functions to ensure timely testing and release of products, collaborate with the team in the design and execution of validation and other projects. Support additional projects as required. Monitor processes and products to identify opportunities for continuous improvement.

**Shift Position**
Sunday - Wednesday / 12pm - 10pm (shift differential offered)

Your key responsibilities include, but are not limited to:
• Perform Bioanalytical testing including flow cytometry, cell count, cell viability, qPCR, etc. in support of clinical release strategies in addition to non-standard studies/projects
• Performs inspections and testing of raw materials.
• Document results within electronic and paper-based systems accordingly.
• Support review of analytical data and archiving in lab documentation systems.
• Support and/or handle tracking and trending systems, and programs that assist in the testing, evaluation and monitoring of quality, assay performance and efficiency. May be required to train other associates in specific areas of competency.
• Ensure assigned analytical methods are ready to be performed when required including management of reagent and equipment inventory
• Support external teams in qualifying new and/or replacement equipment within the laboratory
• Support execution of method qualification/development & optimization/transfer as governed by protocols and/or under the supervision of senior lab staff.
• Draft under supervision basic protocols in support of laboratory execution requirements as per ICH and NVS guidelines
• Contribute to writing of OOS/OOE/OOT and deviation investigations as well as designing CAPA outcomes
• Support Change control and revise SOPs, forms, laboratory test records as required using appropriate electronic systems.
• Support laboratory management in drafting analytical response/strategy documents.
• Support internal and external audits of facility.
• Ensures all assigned training is completed within required time frame



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 Cell Biology Immunology, Molecular Biology, Virology, Biochemistry, Microbiology or other related science required; Master’s degree is a plus.
• 3+ years’ experience in the Pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory
• Thorough knowledge of at least one bioassay test method (e.g. Elisa, Flow cytometry, cell counting using NC 200, DNA extraction, qPCR, cell culture)
• Experience in the use of GxP practices relevant to analytical testing
• Experienced in drafting SOP, Laboratory records, test instructions
• Experience in support/writing OOS/OOE/OOT and/or deviation investigations
• Experience in the use of computer-based systems and applications associated with bioanalytical testing
• Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines preferred

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!


Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
USA
East Hanover, NJ
Quality
Full Time
Regular
No
careers default image
348279BR

Expert Science & Technology (Bioanalytics Scientist)

Apply to Job Access Job Account