Post-Doctoral Scientist Fellow- Large Molecule DPD

Janssen Research & Development, LLC., a division of Johnson & Johnson's Family of Companies is recruiting for a Post-Doctoral Scientist Fellow, located in Malvern, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. The success of messenger RNA (mRNA)-based therapeutics highlights an exciting path forward in precise and individualized treatments for clinically unmet needs. To achieve therapeutic effects, mRNA must be protected from degradation, reach specific target cells, internalize, enter the cytoplasm, and express sufficient proteins of interest. To circumvent these barriers, nanocarrier technologies have been used to encapsulate mRNA and enhance delivery to cells. Targeted delivery, endosomal escape, lipid nanoparticle design, and stability represent significant technical obstacles to mRNA therapeutics. We are seeking a Post-Doctoral Scientist Fellow who will work closely with Large Molecule Drug Product Development (DPD) scientists to address these technical challenges. The fellow will be responsible for experimental studies in pre-formulation, formulation, characterization and analytical development of therapeutic proteins or other biologics including RNA therapeutics, monoclonal antibodies (mAbs), bispecific, fusion proteins, virus like substances, 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, as well as biophysical/analytical method development and data interpretation to analyze different biologics modalities. Responsibilities: Design and execute formulation development experiments for large molecule drug products such as RNA therapeutics, Lipid nanoparticles (LNPs), gene therapy, and viral vector products, and other biologic drug candidates (including vaccines and monoclonal antibodies) in an effort to improve safety, efficacy, stability, and manufacturability. Identification and evaluation of novel LNP formulations, development of bioconjugation methods, purification and characterization of nanoparticles, and development of innovative analytical methods to advance RNA-LNP candidate selection 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 Perform technical analysis of the project data, including trending of data. Author and contribute to scientific publications and/or patents, participate in key scientific meetings and conferences, author technical reports, and present data to peers and functional management Follow general laboratory safety procedures, as related to biologically derived materials and perform duties consistent with good laboratory practices Qualifications Required: PhD degree in Chemical Engineering, Biomedical Engineering, Chemistry, Biomedical Science or related scientific discipline within the past three years or will complete this degree prior to starting the position. Knowledge and experience in formulation development and/or biophysical characterization. Ability to interpret and analyze data from biophysical assays and design appropriate experiments. Must have excellent strong written and verbal communication skills. Preferred: Knowledge of lipid, nucleic acid, and bioconjugation science, including molecule liabilities, biophysical characterization, and LNP formulation methods. Familiarity with biochemical, biophysical and/or analytical methodologies such as separations (i.e. SEC, IEX, etc.), preparative biomolecule purification using automated chromatography systems (HPLC, FPLC), LC/MS characterization of large molecules, fluorescence and UV spectroscopy, physical characterization (i.e. DLS, Zeta Potential, etc.), charge variant analysis, oxidation analysis, and peptide mapping. Consistent track record problem solving and trouble shooting in bio-therapeutics discovery/development environment; Proven ability to independently identify, develop and implement scientific solutions to practical problems At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 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. #JNJPostDoc #JNJResearchandDevelopment Primary Location United States-Pennsylvania-Malvern-200 Great Valley Parkway Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206018397W