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Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal Scientist, Biotherapeutics DPD located in Malvern or Spring House, PA.
At Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can 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: www.janssen.com
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.
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Education:
- A minimum of a Bachelors degree with at least 10 years of relevant experience is required. PhD or PharmD is preferred
Experience and Skills:
Required:
- Significant expertise in Biopharmaceutical 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 GxP 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 sBLA/Type II variation review/approval experience for biologics is preferred
- Education in Pharmacy, Pharmaceutical 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, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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