Senior Scientist, Gene Therapy | Downingtown, PA

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, cardiovascular and metabolism, and pulmonary hypertension.

Please visit http: // for more information. The Senior Scientist, Gene Therapy within the Large Molecule Drug Product Development team will be a lab-based role, responsible for experimental studies in pre-formulation, formulation, characterization and analytical development of gene therapies

and other viral vector modalities for early, mid, and late-stage new molecular entity (NMEs). This includes development and optimization of the technical operations associated with gene therapy manufacturing, 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. Key Responsibilities: Development and optimization of manufacturing process Design and execute studies relating to manufacturing process development, and overseeing the execution of development, small scale to GMP grade manufacturing

processes. 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).

Perform duties consistent with good laboratory practices. Required: Ph. D. with 2-5 years' experience, Master's degree with 5-8 years of experience, or Bachelor's degree with more than 8 years' experience in an appropriate scientific discipline (Chemical or Biomedical Engineering, or related Engineering fields) is required. Experience with viral vector production/characterization. Ability to interpret and analyze data from biophysical assays and design appropriate experiments. Must have excellent strong written and verbal communication skills.

Preferred: Experience in gene therapy or viral modality manufacturing process. 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. Other: This role can be based in Malvern, PA or Spring House, PA and may require up to 10% of travel. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual 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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