Scientist, Bioanalytics

328307BR
Sep 23, 2021
USA

Job Description

10! The number of projects you will participate in as the new Clinical Scientific Expert based at Novartis in East Hanover, New Jersey. As part of the Global Drug Development (GDD) team this role is critical in ensuring clinical trial data and Clinical Study Reports (CSR’s) are of the highest quality throughout the life cycle of each project and ensure they are compliant.

Your responsibilities include, but not limited to;

•**Shift position** Work on shifts covering daytime / evening and one or both weekend days. Shift will be fixed according to business need.
•Perform Bioanalytical testing including flow cytometry, cell count, cell viability, qPCR, etc. in support of clinical release strategies.
•Performs inspections and testing of raw materials.
•Supports and executes non-standard studies/projects as required
•Document results within electronic and paper based systems accordingly.
•Support review of analytical data and archiving in lab documentation systems.
•Support and/or manage 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 review of logbooks as defined by internal procedures.
•Ensures cleanliness of laboratory working areas
•Perform daily equipment startup, shutdown and equipment calibration/PQ (when required)
•Supports 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
•Draft presentations as required
•Contribute to writing of OOS/OOE/OOT and deviation investigations.
•Support in designing CAPA outcomes
•Support Change control as required
•Revise SOPs, forms, laboratory test records as required using appropriate electronic systems.
•Supports laboratory management in drafting analytical response/strategy documents.
•Assists equipment and metrology teams in troubleshooting equipment issues
•Follows GxP quality policies and procedures.
•Drives 5S and Lean projects.
•Support internal and external audits of facility.
•Supports laboratory management in scheduling activities
•Supports Junior staff as required
•Ensures all assigned training is completed within required time frame
•Availability to work weekends if needed.

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;

•BA or MS in Cell biology Immunology, Molecular biology, virology, biochemistry, microbiology or other related science. Advanced degree may be an advantage but not essential.
•Minimum 3 years’ experience in the pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.
•Thorough knowledge of bioassay test methods (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 using LIMS systems
•Experience in support/writing OOS/OOE/OOT and/or deviation investigations
•Proven written and verbal communication skills
•Proven 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.

799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.

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
Global Drug Development
TECHNICAL R & D GDD
USA
East Hanover, NJ
Quality
Full Time
Regular
Yes
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328307BR

Scientist, Bioanalytics

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