Principal Scientist, Quality Control Operations
- East Hanover, NJ
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 Principal Scientist, Quality Control Operations will coordinate and execute all activities to ensure the timely testing and release of all samples, related to development/clinical operations at our Cell and Gene Therapy GMP facility! They will lead and execute compliant analytical initiatives while advising/assisting in functions supporting Quality Control Department. As the subject matter expert on specific areas and techniques, they will provide employees with training and resources to exceed the delivery of quality products and services on time to all customers (internal and external). They will do this all while supervising processes and products to find opportunities for continuous improvement.
Your responsibilities include, but are not limited to:
• As the subject matter in quality control operations, they will provide technical support to external and internal departments regarding microbiological inquiries for new product development, prepare in-depth risk assessment for all new product development and provide microbiology specialist summary for Regulatory submission and perform bioanalytical/microbiology testing in support of clinical release strategies
• A key person for collaboration with global AS&T network and with development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
• Lead with transfer of analytical methods between Analytics Process Science - Quality Control, to other Novartis sites, and to international CMOs.
• Lead and participate in the development and improvement of experimental designs, test plans and processes for existing and new products. Performs evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach.
• Schedules and prioritize work for staff and develop training and analyst qualification programs to perform assays under cGMPs.
• 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.
• Coordinates and supports validation activities including writing protocols/reports, revision of SOPs, forms, laboratory test records as required using appropriate electronic systems while managing protocols in support of laboratory execution requirements as per ICH and NVS guidelines.
• Support Quarterly/Annual Quality planning, site-wide Data Integrity initiative, and perform monthly QC matrixes.
• Provides timely response while leading and/or participating in writing CAPAs/OOS/OOE/OOT and/ or deviation investigations. Support Change Requests through: impact assessment, change initiation, change phase management. (Author/Review Quarterly and Annual OOS Trend Report for QC.)
• Collaborate with QA and regulatory agencies during audits. Assists in preparation to internal and external GMP and HSE audits, including, but not limited to International, Federal (FDA, DEA, EPA, OSHA), State and local regulations as applicable.
• Support 5S and Lean Lab projects; participates in inter-department project teams for analytical input and quality improvements.
• Solid understanding of LabWare LIMS, QC data systems, and all other appropriate GMP quality systems (e.g. eSOPs, Subway, Agile etc.).
• Ensures that all planned, executed and documented activities are aligned/adhere with all company policies/procedures, site objectives related to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends as well as Novartis Quality Standards.
• 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.
• Perform other job duties as assigned.
EEO Statement 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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
What you'll bring to the role:
• Education: Master's or PhD in Biology, Chemistry, Biochemistry, Pharmacy, Microbiology or other related science or work experience.
• Minimum 10 years of related Quality Control pharmaceutical experience (GxP area in manufacturing /Development or QA) with experience in Bio-Analytical method development/qualification and/or operating within an aseptic manufacturing facility, biotechnology or advance therapy medicinal products.
• Previous people management experience preferred.
• Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines. Including the ability to run projects and lead teams utilizing modern project management methodology and tools.
• Demonstrated knowledge and skills in multiple analytical techniques and expertise in ICH and FDA/EMEA GMP requirements.
• Knowledge of LIMS systems, Change Control systems, such as Agile PLM and Quality Management Systems, such as Trackwise.
• Detail-oriented with expertise in problem solving and solid decision making abilities
• Strong verbal and written technical communication skills.
• Position will be filled at level commensurate with experience.
• Cell and gene therapy experience is preferred.
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
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
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