343513BR
Apr 08, 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 & Technology will perform bioanalytical testing and other activities in functions supporting the Bioanalytics department related to development/clinical operations at our Cell and Gene Therapy GMP facility.

Your responsibilities will include, but are not limited to:

• Perform bioanalytical testing in support of clinical release strategies and activities compliantly following appropriate SOPs and procedures.
• Document results within electronic and paper based systems accordingly.
• Peer review and archive analytical data in lab documentation systems. Support monthly review of laboratory logbooks and monthly laboratory cleaning.
• Handle reagent and equipment inventory for assigned areas of responsibilities.
• Perform daily equipment startup and shutdown; ensures cleanliness of laboratory working areas
• Participate in deviation investigation/CAPA implementation in a timely manner and support OOS/OOE/OOT and deviation investigations.
• Follows GxP quality policies and procedures.
• Ensures all assigned training is completed within required period and draft presentations as the need arises.
• Identify process improvements to support 5S and Lean projects.
• Interface with regulatory agencies during audits.
• Knowledge of LabWare LIMS, QC data systems and other GMP/GLP quality systems (eSOPs, TEDI, etc).
• Work on shifts covering daytime/evening and one or both weekend days. Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need.
• Performs other job duties as assigned.


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:

• Bachelors in Cell biology Immunology, Molecular biology, virology, biochemistry, microbiology or other related scientific field or equivalent work experience.
• 1+ year(s) of relevant experience in either industry (pharmaceutical, biologics, microbiology, sterile manufacture, or medical device) or academic/lab setting with knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. ANSI, ISO, etc.).
• Understanding of bioassay test methods (Elisa, Flow cytometry, qPCR, cell culture).
• Knowledge of LIMS systems.
• Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
• Detail-oriented with expertise in problem solving and solid decision making abilities.
• Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
• Sound, practical and appropriate regulations with regards to Novartis.
• Strong written and verbal communication skills are crucial.
• Experienced in the use of computer based systems and applications.
Global Drug Development
TECHNICAL R & D GDD
USA
East Hanover, NJ
Quality
Full Time
Regular
No
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343513BR

Associate Expert, Science & Technology (Bioanalytics Testing)

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