Expert Science & Technology (QC Bioanalytics)
- East Hanover, New Jersey, United States
- Closing date
- Feb 16, 2023
- Other, Manufacturing/QA/QC
- Position Type
- Full Time
- Organization Type
1 purpose! Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
Expert 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: Wednesday - Saturday / 12pm - 10pm***
Your responsibilities will 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
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.
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
The pay range for this position at commencement of employment is expected to be between $84,000 and $126,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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.
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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