Johnson & Johnson Careers
Principal Scientist, Drug Product Development Scientific Integrator (1 of 2)
Requisition ID: 4990180625
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Principal Scientist, located in Malvern, 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. Please visit http://www.janssenrnd.com/ for more information.
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 scope of the DPD Scientific Integrator (SI) function is 'End-to-End' and applies to all biological drug projects, developed and/or manufactured internally and externally. The DPD SI leads a team of DPD and cross-functional scientific experts including formulation, fill/finish process, Pharmaceutical and Material Sciences, Packaging Development and Engineering, Drug Delivery & Device Development, and Supply Chain Technical Operations, integrating DPD activities so that deliverables are being met balancing cost/time/quality. Specifically, the DPD SI will provide scientific technical leadership, ensuring the focus on scientific excellence is maintained within the DPD/CMC teams. The SI is a core member of the CMC team, with key interactions with the API and Analytical integrators, quality, regulatory, clinicians, technical groups, external vendors and partners as well as the Portfolio Management Functions. Main responsibilities include:
Developing and implementing the global DPD strategy and plan per product, in line with the overall strategy and plan as outlined by the CMC team, enabling the CMC team to optimize the science within DPD. The successful candidate will ensure alignment and endorsement of this strategy within the DPD function.
Developing clear value-added DPD objectives aligned with the DPD and CMC strategy, and effectively communicating the strategy and objectives within the DPD team as well as to other stakeholders.
Working with the senior functional leaders of Drug Product Development and the CMC Leader to ensure rapid identification and resolution of problems.
Delivering an enhanced focus on the scientific rigor within the CMC teams and within DPD, ensuring consistent scientific excellence and scientific quality standards are met.
Driving the Target Product Profile (TPP)-CMC agreement & deliverables in partnership with the CMC team leader, the Supply Chain, Marketing and the Compound Development Team (CDT).
Delivering the clinical and commercial formulations & manufacturing processes, meeting the manufacturing performance, cost and process robustness needs, in line with Quality by Design (QbD) principles.
Ensuring complete, consistent, comprehensive, high quality submission clinical and marketing dossiers.
Optimizing the DPD development methodology, where possible making use of standard technology platforms, accelerating development timelines, and streamlining the technical transfer process.
A Master’s Degree or PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with 7 years of experience is required
Demonstrated competency and experience in biologic drug product development within the pharmaceutical industry with a high level of technical understanding is required
Demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is required
Demonstrated experience in scale up of manufacturing processes and technical transfer of projects into commercial manufacturing is preferred
Drug Product Development experience that spans early through late is preferred
Experience in vaccine, gene, and/or cell therapy product development is preferred
This position will be based in East Coast, US and may require up to 15% international and domestic travel
Janssen Research & Development, LLC. (6084)