Associate Expert Science & Technology (QC Bioanalytics)
- East Hanover, New Jersey, United States
- Closing date
- Feb 15, 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.
The Associate Expert, Science & Technology direction 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.
***Shift Position: Sunday - Wednesday / 12pm - 10pm***
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.
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 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.
The pay range for this position at commencement of employment is expected to be between $59,900 and $89,900 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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