Principal Scientist Formulations

Johnson & Johnson • Malvern, PA

3d • Onsite

About The Position

The Principal Scientist, Protein Formulations is a lab-based individual contributor in Johnson & Johnson’s Protein Drug Product Development & Delivery department. The role supports formulation development and involves managing or contributing to scientific projects, programs, and processes. The scientist designs and executes experimental studies in pre-formulation, formulation, and biophysical characterization of therapeutic proteins and other biologics, including monoclonal antibodies, multispecifics, fusion proteins, and mixed conjugates. The work includes developing and optimizing technical operations for liquid biologics, diluent compatibility and administration studies, and stability campaigns.

The scientist interprets complex datasets and communicates their impact to stakeholders through formal and informal disclosures. The role also evaluates and develops technologies in emerging drug-delivery fields to enhance the protein portfolio.

Requirements

• Ph.D. in an appropriate scientific discipline, such as Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, Biophysics, or Chemistry, and at least 3 years of industry-relevant experience; or an M.S. degree and at least 6 years of experience.
• Strong understanding of protein stability, thermodynamics, and biophysical characterization techniques.
• Experience with protein biophysical characterization and chromatography techniques, including HPLC, fluorescence and UV spectroscopy, light scattering (such as SLS and DLS), particle analysis (such as MFI and HIAC), and separation methods (such as CEX, cIEF, and HIC).
• Ability to identify protein liabilities and perform developability assessments from pre-clinical through commercial readiness.
• Ability to interpret and analyze data from biophysical and biochemical assays and design appropriate experiments.
• Technical writing skills, including maintaining high-quality documentation and preparing reports, SOPs, or other technical reports.
• Ability to use emerging developments in drug delivery to lead new technical and research initiatives.
• Ability to work with multidisciplinary teams.

Nice To Haves

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

Responsibilities

• Design, execute, analyze, and document studies to develop and optimize formulations for biologic therapeutics.
• Conduct studies involving biophysical characterization, stability, composition and excipient selection, freeze/thaw, mixing, clinical administration, robustness, and administration-protocol development.
• Interpret complex datasets and communicate their impact to stakeholders through formal and informal disclosures.
• Evaluate and develop emerging drug-delivery technologies to enhance the protein portfolio.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree