Bioanalytical Portfolio Manager
Bioanalytical Portfolio Manager
Job Description5600 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 patients, then look no further, NIBR is the place to be. As a Bioanalytical Portfolio Manager in the Translational Medicine PK Sciences group, you will have the opportunity to make a difference. Come work on one of the most diverse sets of modalities in the pharma industry. We are looking for professionals with expertise in 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 and may be based in Cambridge, MA, East Hanover, NJ or Basel, Switzerland. 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 Portfolio Manager (senior biologics expert) your responsibility is to ensure the continuity of bioanalytical science and strategy of projects, with scope spanning late discovery to post-marketing.
Your responsibilities will include but are not limited to:
• Work with project teams to devise the bioanalytical strategy for a wide range of biologics, including gene therapies, cell therapies, monoclonal antibodies, bi-trispecific/ScFV antibodies, oligonucleotides/ siRNA, proteins and peptides, from early preclinical through to clinical development.
• Manage and monitor bioanalytical activities for a wide range of biologics outsourced to external partners. Communicate with clinical teams / stakeholders. Oversee development and qualification of bioanalytical assays at CROs for PK, TK, PD and ADA.
• Contribute to immunogenicity risk assessment of biologics consistent with current health authority expectations.
• Advise project teams on regulatory requirements and strategy as compounds progress through the pipeline.
• Compose relevant bioanalytical sections of regulatory and submission documents (e.g. briefing book, integrated summary of immunogenicity, IB, CTD) as needed.
• Liaise with partners within PKS and in other NIBR functions to proactively identify scientific gaps and needs in bioanalytical support, and work within the bioanalytical group to address these.
• Maintain comprehensive knowledge of the latest developments/recommendations from regulators and from societies such as EBF or AAPS and stay abreast of the evolving NIBR portfolio, while updating partner bioanalytical functions of major project milestones and developments.
• Be the point-of-contact within the bioanalytical group for due diligence of compounds by critically evaluating bioanalytical assays, activities, and data quality.
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?
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.
Minimum requirementsWhat you’ll bring to the role:
• Candidates with 12+ years of experience relevant to this position in the pharmaceutical/CRO/related industry with a PhD in chemistry, biochemistry, immunology or related field are preferred. Title will be commensurate with candidate qualifications & experience.
• Strong scientific and operational background in ligand binding assays, qPCR techniques, cellular assays (e.g., flow cytometry, receptor occupancy and cellular immunogenicity assays). Experience with liquid chromatography/mass spectrometry is preferred.
• 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 and molecular biology/biochemistry techniques. Previous hands-on experience with liquid chromatography/mass spectrometry assays would be an asset.
• Strong interpersonal communication skills, presentation 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!
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.