Scientist, Large Molecule Drug Product Development
Posted on Apr 6, 2021 by Johnson & Johnson
Janssen Research & Development, LLC., a division of Johnson & Johnsons Family of Companies is recruiting for a Scientist, located in Spring House, 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The 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 cell and gene therapies including CAR-T and viral vector modalities for early, mid, and late stage new molecular entity (NMEs). This includes development and optimization of the technical operations associated with aseptic technique, formulation and fill/finish, cryopreservation, diluent compatibility/administration relevant studies, as well as execution of characterization plans 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:
Development and optimization of drug product formulations
Execution of characterization plans and stability studies with the goal of developing a better understanding of stabilization mechanisms.
Lead or participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions, and successfully resolve problems with supplies, methods, project issues, and deviations.
Perform technical analysis of the project data, including trending of data.
Author technical reports and regulatory filling. Present data to peers and functional management.
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).
Design and execute studies relating to formulation and filling unit operations including mixing, vial, bag, and syringe filling, cryopreservation, and overseeing the execution of development, small scale to GMP grade fill/finish manufacturing processes.
Design and execute compatibility studies to support administration of large molecules.
Design and manage stability studies on target and experimental formulations.
Perform duties consistent with good laboratory practices.
Ph.D. 0-2 years' experience, M.S. 5-8 years' experience, or B.S. + > 8 years' experience in an appropriate scientific discipline (Life Sciences or Chemical Engineering) is required.
Working knowledge of flow cytometry.
Experience with mammalian cell culture.
Ability to interpret and analyze data from biophysical assays and design appropriate experiments.
Must have excellent strong written and verbal communication skills.
Experience in CAR-T production/culture.
Experience with mammalian cell cryopreservation/cryobiology.
Experience with characterization of T cell subpopulations and an understanding of immunology.
Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety guidelines.
Experience mentoring others in a Matrix environment.
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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