Senior Scientist, Analytics and Formulations

Job Description

6000! This is the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on new technologies that have the potential to contribute to therapeutic breakthroughs for patients. The Biotherapeutic Engineering and Gene Therapy drives a diverse portfolio of modalities including therapeutic proteins, multi-specific antibodies, CAR-T, RNA therapeutics, AAV and lentiviral vectors. We work collaboratively with disease area groups to broaden the use of biologics in therapeutic applications.

We are looking for a passionate Senior Scientists to join our characterization and formulation team in Cambridge, MA to develop a diverse portfolio of biotherapeutic modalities. In this role, you will work on pre-formulation and characterization of lentivirus (LV) based therapeutics and other new modalities during discovery and early development while driving formulation strategy for gene therapy-based therapeutics and other large biomolecules before the project transition into early phase development and help funnel out unfavorable candidates with respect to formuation assessment. The diversity of projects and tasks in our organization offer various areas for you to influence and to develop further. The position offers a unique opportunity to gain experience in a wide range of preformulation assessment and broad spectrum of biologics modalities, with chances to create significant experimental and intellectual contributions to our organization.

The Characterization and Formulation Unit in NBC characterizes new therapeutic protein candidates of various formats throughout discovery to the handover to development. Our team of skilled scientists from various backgrounds provide expertise in areas such as phys-chem analytical characterization, mass spectrometry, and pre-formulation assessment in an international setting.

What you’ll be doing: Your responsibilities include, but are not limited to:
• Design and develop preformulation assessment for large biotherapeutics focusing on Lentivirus modalities
• Hands on experience with implementing and developing a method to assess for particle counts, aggregation, degradation etc. using FFF-MALS or similar techniques specific to Lentivirus characterization
• Lead screening experiments to identify stable formulations, and collaborate results and designs independently to research and development organizations
• Execute preformulation assessment including but not limited to solubility assessment, set-up of formulation screening studies, performing biophysical characterization methods such as DSC, dynamic light scattering (DLS), UV-Vis, turbidity, sub visible particle assessment, viscosity and other techniques that are PCR based, LC based method (SEC, HIC) for characterizing therapeutic proteins, Lentivirus and other new modality molecules
• Implement state-of-art high-throughput screens using automated liquid handler systems for preformulation assessment
• In depth knowledge of gene therapy-based formulation studies performed in early-stage development of biotherapeutics with an understanding of stabilizing clinical candidates for liquid, frozen liquid and lyophilized drug product presentations
• Apply physico-chemical analytics methods for candidate and process characterization of various formats of biotherapeutics in screening, formulations, lead optimization and development stages
• Operate and maintain instrumentations, perform data analysis and ELN documentation, and author and/or review method development and technical reports.
• Work in a highly interdisciplinary and collaborative environment as part of the global NBC team and contribute to data analysis and interpretation, making technical presentations and report writing
• Interact and collaborate with colleagues in biologics across Discovery and Development organizations.
This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require 0% travel as defined by the business (domestic and/ or international).

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.

Minimum Requirements

What you’ll bring to the role:
• B.S/M.S in pharmaceutical sciences, chemistry, biochemistry or related field with preferably 5+ years of biotech/biopharmaceutical industry experience, or PhD. in related field with 0-2 years of biotech/biopharmaceutical industry experience.
• Hands-on experience with gene therapy drug delivery and characterization assays such as Dynamic Light Scattering (DLS), Cryo-EM, FFF-MALS, MALS etc.
• Demonstrated technical understanding and expertise in the field of formulation sciences of large biotherapeutic molecules with a preferred knowledge of novel drug delivery systems
• Demonstrated expertise with hands-on experience of setting up preformulation assessments and use of different stability indicating assays such as SEC/CE/DLS (including but not limited to) to interpret the formulation studies data
• Demonstrated scientific curiosity, problem-solving skills, and ability to design and execute experiments independently
• A great teammate, who is detailed, can multi-task, and outstanding in oral / written communication skills.

Desirable

• Knowledge on lipid-based nanoparticle is a plus.
• Direct experience with Lentivirus formulations and characterization.
• Experience with JMP DoE software to design high throughput formulation screening would be preferred.
• Experience with liquid handler.

Why Novartis
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!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected] .