Principal Scientist Formulations

About This Role

This lab-based role focuses on protein science and supports formulation development within the Protein Drug Product Development & Delivery department. The Principal Scientist will be an experienced individual contributor, managing or contributing to scientific projects, programs, and processes. The role involves designing and executing experimental studies in pre-formulation, formulation, and biophysical characterization of therapeutic proteins or other biologics.

Responsibilities

• Design, execute, analyze, and document studies to develop and optimize formulations for biologic therapeutics
• Conduct studies including, but not limited to, biophysical characterization, stability, composition selection, excipient selection, freeze/thaw, mixing, clinical administration, robustness, and development of administration protocols
• Accurately interpret complex datasets and effectively communicate impact to stakeholders through formal and informal disclosures
• Evaluate and develop technologies in emerging fields of drug delivery to enhance the protein portfolio

Requirements

• Ph.D. in an appropriate scientific discipline such as Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, Biophysics, Chemistry, etc., and 3+ years of industry relevant experience or an MS degree with 6+ years of experience
• Strong understanding and knowledge of protein stability, thermodynamics, and biophysical techniques for characterization
• Experience with protein biophysical characterization and chromatography techniques such as HPLC, fluorescence and UV spectroscopy, light scattering (e.g. SLS, DLS), particle analysis (e.g. MFI, HIAC), and separation methods (e.g. CEX, cIEF, HIC)
• Ability to identify protein liabilities and perform developability assessments for products from pre-clinical to commercial readiness
• Ability to interpret and analyze data from biophysical and biochemical assays and design appropriate experiments
• Technical writing skills, including the ability to maintain high-quality documentation and prepare reports, SOPs or other technical reports
• Ability to use emerging developments in drug delivery to lead new technical and research initiatives
• Capable of working with multi-disciplinary teams

Nice to have:

• Understanding of regulatory pathways for large molecule therapeutics
• Experience with authoring and reviewing regulatory filings supporting IND, IMPD, BLA, or MAA
• Proven publication and presentation history and involvement with scientific organizations or conferences

About the Company

At Johnson & Johnson, health is everything. The company's strength in healthcare innovation empowers it to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through its expertise in Innovative Medicine and MedTech, Johnson & Johnson is uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to its employees who work throughout the world, providing an inclusive work environment where each person is considered as an individual, respecting their diversity and dignity, and recognizing their merit. Its expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel science-based advancements.