Bioanalytical Scientific Monitor, PK Sciences
- East Hanover, NJ
5600 scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis the premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, and want to positively impact society by speeding delivery of novel therapies to needy patients, then look no further, NIBR is the place to be. As a Bioanalytical Scientific Monitor in the Translational Medicine PK Sciences Bioanalytical group, you will have the opportunity to make a difference. Bring your collaborative nature, commitment to teamwork and relentless focus on improving patient care to us. We are looking for professionals with expertise in clinical bioanalytics of biologics who want to work with the latest therapeutic modalities: gene therapies, cell therapies, bi-trispecific/ScFV antibodies, oligonucleotides/ siRNA, proteins and peptides. The role is within NIBR at our US Pharma Headquarters in East Hanover, NJ. If you have a collaborative nature, a commitment to teamwork and a relentless focus on improving patient care we want you to apply.
As a Bioanalytical Scientific Monitor in NIBR Translational Medicine's PK Sciences Bioanalytical group, you will have overall responsibility for overseeing method development, validation, and implementation of immunogenicity and pharmacokinetic assays at CROs as primary endpoints, and/or for safety assays for biologics development, clinical studies and post-marketing studies.
Your main responsibilities include but are not limited to:
• Conduct bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidelines
• Manage and monitor bioanalytical activities outsourced to external partners. Act as the interface with clinical teams / stakeholders. Development and qualification of bioanalytical assays at CROs for PK, TK, PD and ADA as well as supporting other new modalities such as oligonucleotides and cell and gene therapies.
• Contribute to immunogenicity risk evaluation, applying in-silico, cellular and mass spectrometric tools for first-in-human clinical study risk evaluation for biologics
• Lead Immunogenicity data interpretation within study teams and provide consultation and technical support for preclinical and clinical immunogenicity strategy discussions within Global BA.
• Contribute to relevant bioanalytical sections of regulatory and submission documents (e.g. IB, CTD.) as needed
Additionally, you will contribute to the strategic direction and leadership for staff, build strong teams, attract and develop diverse talent. In setting the standard for conducting cutting edge research, many things have changed at NIBR, but some things stay the same: a collaborative nature, a commitment to teamwork across the organization and a relentless focus on improving patient care. Do you want to be part of a global pharmaceutical leader that has reinvented the paradigm of drug development while maintaining its unwavering commitment to bringing the latest breakthrough therapies to our patients?
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 will bring to the role:
PhD and 4 plus years of related experience in pharmaceutical/CRO/related industry
• Strong scientific and operational background in ligand binding assays, qPCR techniques and cellular assays (e.g., flow cytometry, receptor occupancy and cellular immunogenicity assays)
• Fundamental understanding of immunogenicity assay development and qualification. Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data
• Previous hands-on lab experience using various ligand binding techniques and molecular biology/biochemistry assays
• Strong interpersonal communication skills and ability to thrive in a dynamic matrixed working environment
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!
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