Senior Scientist, Quality Control Analytics (Sun - Wed 7am - 5:30pm)

　　Job ID

　　390774BR

　　Jan 24, 2024

　　USA

　　About the Role

　　Location: Onsite - Morris Plains, NJ

　　Shift: Sunday - Wednesday 7:00am - 5:30pm

　　EVP: 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.

　　The Senior Scientist, Quality Control Analytics will coordinate and execute all activities to ensure the timely testing and release of all samples, collaborate with team in the design and execution of validation and other major projects. Provide employees with training and resources to meet or exceed customer requirements. Monitor processes and products to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas and techniques and proactively provides education technical knowledge and skills to less experienced scientists.

　　• Support Bioanalytical laboratory by execution of in-process and release testing on batches including, but not limited to, flow cytometry, IFNg potency, qPCR, cell count and viability, sterility, and endotoxin.

　　• Coordinate and act as liaison for other departments

　　• Execute and supervise peer review of analytical data and archiving in lab documentation systems.

　　• Support and manage tracking and trending systems, KPIs and Quality Metrics

　　• Drives execution of method qualification/development & optimization/transfer as governed by protocols. Draft under supervision protocols compliant with ICH and NVS expectations

　　• Perform analyses and determine appropriate actions with regards to lab investigations, deviations, CAPAs, change control and continuous improvement to ensure continued compliance with all cGMP requirements.

　　• Assists and supervises equipment and metrology teams in troubleshooting equipment issues

　　• Lead and develop best practices within the team including fostering Lean principles.

　　• Support internal and external audits of laboratory facility as a recognized SME.

　　• Mentor and coach staff members for ongoing growth and leadership

　　Key Performance Indicators

　　• Self-directed with a high degree of professional integrity, highly organized and detail oriented with the ability to work independently and with the team.

　　• Flawlessly delivers quality results on time to all customers, internal and external. Recognized specialist in any particular field of laboratory matters and is capable to confidently communicate technical information to regulatory inspectors.

　　• Escalate issues and potential solutions to laboratory management in a timely manner.

　　• Demonstrated critical reasoning, strategic thinking, problem solving, troubleshooting, influencing and decision-making skills.

　　Diversity & Inclusion / EEO

　　We 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.

　　Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

　　Novartis: e-mail [email protected] or call +1 (877)395-2339

　　Sandoz: e-mail [email protected] or call: +1-609-422-4098

　　Role Requirements

　　Education: 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.

　　Languages: Fluent in English with Advanced written and verbal communication skills

　　Experience:

　　• Minimum of 5 years’ experience in the pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory as well as a thorough knowledge of cGxP expectations.

　　• Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines.

　　• Thorough general knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, qPCR, cell culture)

　　• SME level knowledge of a particular area of bioanalytical testing

　　• Experience using LIMS systems

　　• Experienced in writing OOS/OOE/OOT and/or deviation investigations

　　• Experience in supporting internal and/or external laboratory audits

　　• Advanced experience in the use of computer-based systems and applications associated with bioanalytical testing

　　Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

　　https://www.novartis.com/about/strategy/people-and-culture .

　　The pay range for this position at commencement of employment is expected to be between $97,600 - $146,400 salaried; 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. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

　　You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

　　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.

　　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: Novartis Talent Pool.

　　Division

　　Operations

　　Business Unit

　　QUALITY

　　Location

　　USA

　　Site

　　Morris Plains, NJ

　　Company / Legal Entity

　　Novartis Pharmaceuticals

　　Functional Area

　　Quality

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　Yes