Senior Scientist, Large Molecule Drug Product Development
Posted on Apr 5, 2021 by Johnson & Johnson
Janssen Research & Development, LLC., a division of Johnson & Johnsons Family of Companies is recruiting for a Senior Scientist, Large Molecule Drug Product Development located in Malvern, PA or Springhouse, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
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The Senior Scientist in the Large Molecule Drug Product Development will be a lab-based role, responsible for experimental studies in pre-formulation, formulation, characterization and analytical development of therapeutic proteins or other biologics including monoclonal antibodies (mAbs), bispecific, fusion proteins, virus like substances, RNA therapeutics, gene therapy and mixed conjugates. This includes development and optimization of the technical operations associated with liquid and lyophilized biologics development, diluent compatibility/administration relevant studies and stability campaigns. In addition, biophysical/analytical method development and data interpretation to analyze different biologics modalities is required.
Major Duties And Responsibilities To Include:
Design and execute formulation development experiments for large molecule drug products such as gene therapy, viral vector products and RNA therapeutics as well as other biologic drug candidates (including vaccines and monoclonal antibodies),
Rational formulation design/selection and characterization studies relevant to the stage of development. Studies include, but are not limited to, biophysical characterization, stability, composition selection and robustness and development of administration protocols.
Design and execute process development studies to determine and characterize process parameters associated with preparation of drug products for RNA therapeutics, gene therapy and viral vectors, and other biologic drug products. Studies include, but are not limited to, freeze-thaw, mixing, filtration, pumping, filling, biophysical characterization, stability, composition robustness and lyophilization.
Development of analytical and characterization methods to support drug product development.
Design and execute studies to understand how the drug product interacts with the product contact material surfaces during fill/finish manufacturing and during dosage preparation.
Development and optimization of liquid and lyophilized biologics formulations, as well as execution of characterization plans and stability studies
Design and execute compatibility studies to support administration of large molecules
Design and manage stability studies on target and experimental formulations
Perform technical analysis of the project data, including trending of data.
Author technical reports and present data to peers and functional management
Follow general laboratory safety procedures, as related to biologically-derived materials
Collaborate with functional line management as well as scientists in related functional areas such as Research and Development, QC/QA, Clinical, Manufacturing, Toxicology, and Regulatory (CMC)
Perform her/his duties consistent with good laboratory practices
Bachelor's degree with 8 or more years' experience, in an appropriate scientific discipline is required.
Master's degree with 5 or more years' experience is required
Ph.D. with 3 or more years' experience is required
Knowledge and experience in formulation development and biophysical characterization required
Ability to interpret and analyze data from biophysical assays and design appropriate experiments required
Must have excellent strong written and verbal communication skills required
Knowledge of viral vectors, RNA, lipid nanoparticles formulation development preferred
Knowledge and experience in development and commercialization of large molecules preferred
Knowledge of protein science, including molecule liabilities and biophysical characterization preferred
Familiarity with pharmacy procedures for drug preparation and human administration preferred
Familiarity with biochemical, biophysical and/or analytical methodologies such as separations (ie SEC, IEX, etc.), fluorescence and UV spectroscopy, physical characterization (ie DLS, Zeta Potential, etc.), charge variant analysis, oxidation analysis, and peptide mapping preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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