PRINCIPAL SCIENTIST, LARGE MOLECULE, DRUG PRODUCT DEVELOPMENT AND DELIVERY

Janssen Research & Development, LLC, a division of Johnson & Johnson’s Family of Companies is recruiting for a Principal Scientist, located in Malvern or Spring House, PA.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/ 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 protein and antibody drug conjugate (ADCs) 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.).
Collaborate with external partners to enable drug product development and clinical manufacturing readiness 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.
Qualifications Education.
a Ph.
.
or Pharm.
.
with a minimum of 10 years experience OR a Bachelor’s degree with 15 years of relevant experience or equivalent experience is required 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 Experience in CMC development of ADCs 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 Familiar with GxP compliance is required Familiar with ICH regulatory guidelines is required Preferred.
Preferred experience in late-stage ADC development and filing is preferred IND/IMPD, BLA/MAA, and sBLA/Type II variation review/approval experience for biologics is preferred Preferred education in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or equivalent is preferred Demonstration of 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.
areers.
nj.
om