Principal Scientist, Biotherapeutics DPD | Downingtown, PA

count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension.

Visit us: The Principal Scientist in the Large Molecule (LM) Drug Product Development and Delivery (DPD&D) team will work as a Scientific Integrator for late development biologic programs with a specific focus on the exciting area of cell therapy! Key Responsibilities: DPD&D scientific

integrator for late development asset(s) leading the development team to deliver on the overall program strategy. Build the program strategy in collaboration with the broader CMC Team (analytical, drug substance, regulatory, quality, supply chain, etc.

). Enables scientists to cultivate new scientific insights; and provide development opportunities working under indirect supervision with a high level of autonomy. Identifies and analyzes high-impact, complex and cross-departmental scientific/technical issues and gaps. Improves, changes or develops new business/work processes to share knowledge, build intellectual capital, build strategic technical capabilities and promote innovation

throughout the organization. Identifies novel scenarios and solicits acceptance of new insights, approaches, concepts through scientific leadership and acts as an internal expert with a direct impact on JRD/JSC scientific and/or business objectives.

May serve as the liaison between team members and senior leadership. Education: A minimum of a Bachelors degree with at least 10 years of relevant experience is required. Ph D or Pharm D is preferred Experience and Skills: Required: Significant expertise in Biomedical Dosage Forms, Drug Delivery systems and the overall drug development process through demonstrated experience and positive track record in multiple R&D or Commercial is required Parenteral drug product development and technology transfer experience is required Demonstrated matrix team leadership experience with a proven track record of directly leading sophisticated team(s) is required Ability to cultivate team efficiency and cohesiveness and to work collaboratively to implement, deliver and get results through the team is required Familiarity with Gx P compliance is required Familiarity with ICH regulatory guidelines is required Preferred: Experience in late-stage cell therapy development and fling is preferred IND/IMPD, BLA/MAA, and s BLA/Type II variation review/approval experience for biologics is preferred Education in shop, medical Sciences, Chemical Engineering or equivalent is preferred Demonstration of strong people leadership in past roles cultivating successful teams is 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, 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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