Principal Scientist, Drug Product Development Scientific Integrator Job

Job description

Principal Scientist, Drug Product Development Scientific Integrator-7122150903DescriptionJanssen Research & Development, LLC ., a division of Johnson & Johnson's Family of Companies is recruiting for an Principal Scientist, located in Raritan, NJ, Spring House, PA, Titusville, NJ or 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 Senior/Principal Scientist SI leads a sub team of DPD scientists including drug product formulation development (Oral Solid Dosage (OSD) or Parenterals & Liquids (PLG)), Pharmaceutical and Material Sciences (PMS), Packaging Development and Engineering and Drug Delivery & Device Development. This team is responsible for integrating DPD activities so that project deliverables are being met balancing cost/time/quality. Specifically, the Scientific Integrator (SI) will provide scientific technical leadership, ensuring the focus on scientific excellence is maintained within the DPD/CMC teams.
Main responsibilities include: Defining the DP development strategy across all program phases (clinical, commercialization and life cycle management) and delivering the Target Product Profile (TPP) through in depth understanding of the compound properties, formulation processing and drug product performance and stability and alignment with DPD functions, CMC and Compound Development teams (CDT); Driving the project advancement (pre-NME – to transfer of ownership) in partnership with DPD functions, CMC lead, CDT functions (preclinical and clinical), Janssen Supply Chain (JSC) while ensuring scientific standards are and achieving a full understanding of drug product and process behavior; Overseeing the planning and execution of DPD project deliverables; Delivering robust clinical and commercial formulations and manufacturing processes, meeting manufacturing performance, cost needs, in line with QbD/DTV principles; The SI will serve as a core member of the CMC team, with key interactions with API and analytical integrators, clinicians, technical groups, external consultants and vendors as well as portfolio management functions; The scientific integrator will also connect to and collaborate with other functions/partners such as QA, JSC, Global Technical Services, RA, PD&S, QS; Leading and providing technical leadership to a team of DPD scientists including OSD, PLG, PMS, packaging development, Clinical Supply Chain (CSC) engineers and device development, ensuring the focus on scientific excellence is maintained within the DPD/CMC teams; During technical transfer, leading the interactions with the manufacturing plant Technical Launch Integrators to ensure efficient and successful implementation of the formulation process at large scale; During interaction with external CROs and CMOs, defines development and business strategies for effective management of project deliverables, and ensures CRO/CMO activities are managed within DPD sub-team; Leading the BioPharm team, composed of CMC, clinical, preclinical, regulatory, toxicology and/or other relevant functions, ensures correct formulation selection in view of the required PK profile, to determine bridging strategies, to define CRC's and ultimately correct specs; Driving the cross-functional, Level 2 Governance Review for the assigned projects; Managing the DP risk register and defines mitigation plans. He/she will ensure rapid identification and resolution of problems.
QualificationsA Masters Degree in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 10 years of experience OR a PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 7 years of experience is requiredDemonstrated competency and experience in drug product formulation development within the pharmaceutical industry is requiredDemonstrated high level of technical understanding of drug product development and processing is requiredDemonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is requiredDemonstrated experience in scale up of formulation manufacturing processes and technical transfer of projects into commercial manufacturing is preferredDrug Product formulation Development experience in small molecule oral and parenteral products is preferredDrug Product formulation Development experience that spans early through late clinical phases is preferredDrug Product formulation Development experience in novel formulations and drug/device combos is preferredThis position will be based in New Jersey or Pennsylvania, US and may require up to 25% international and domestic travelBE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:BIOJ2W: LI NAPrimary Location:North America-United States-New Jersey-RaritanOther Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-MalvernOrganization: Janssen Research & Development, LLC. (6084)Job Function: R&DCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement