Principal Scientist Formulations
About The Position
Johnson & Johnson is seeking a Principal Scientist, Protein Formulations, for its Protein Drug Product Development & Delivery department in Malvern, Pennsylvania. This lab-based individual-contributor role calls for expertise in protein science and support of formulation development. The scientist will manage or contribute to scientific projects, programs, and processes. The role involves designing and executing experimental studies in pre-formulation, formulation, and biophysical characterization of therapeutic proteins and other biologics, including monoclonal antibodies, multi-specifics, fusion proteins, and mixed conjugates. Work includes developing and optimizing technical operations for liquid biologics, diluent compatibility and administration studies, and stability campaigns. The scientist will assess emerging drug-delivery technologies 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 relevant industry experience; or a master'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 conduct developability assessments from preclinical through commercial readiness.
- Ability to interpret and analyze biophysical and biochemical assay data and design appropriate experiments.
- Technical writing skills, including maintaining high-quality documentation and preparing reports, SOPs, or other technical reports.
- Ability to use emerging drug-delivery developments 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 development of administration protocols.
- Interpret complex datasets and communicate their impact to stakeholders through formal and informal disclosures.
- Evaluate and develop technologies in emerging drug-delivery fields to enhance the protein portfolio.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
