Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Principal Pharmacist, 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 successful candidate is for a Principal Pharmacist role and will work on the biologics drug dosing design and administration within Drug Product Development – Large Molecule (DPD-LM) department. The incumbent will provide Drug Product Development oversight for Pharmacy Manual Studies including drug product design, development of investigational product preparation instructions (IPPIs) and support of IPPIs with practitioners at study centers. Responsibilities include but are not limited to:
Providing subject matter expertise in all areas of drug product design, dosage preparation, administration and instructional training as well as ensuring an open & consistent communication among DPD teams, Clinical teams and Clinical Study sites
Collaborate with DPD Formulation Scientists, Global Trial Mangers, Clinical Physicians, Study Managers and Pharmacists to ensure that the IPPI protocol can be executed at clinical sites for Phase 1 to Phase 3 clinical studies
Creating workflows for drug product in-use stability/compatibility studies
Creation of investigational product preparation instructions (IPPIs), IPPI training at clinical study sites
Providing effective communication with pharmacists at clinical sites
Benchmark our practices to reflect standard clinical pharmacy practices and provide tactical/scientific mentorship to project scientists
- BS degree in Pharmacy, Pharmaceutical Sciences or a related field with at least 13 years of experience OR a MS, Pharm. D. or other advanced degree in Pharmacy, Pharmaceutical Sciences or a related field with at least 11 years of experience is required.
- Must have a current and active Pharmacist License is required
- Knowledge and experience of Pharmaceutical and/or clinical drug development is required
- Knowledge and understanding of scientific process that are used to deliver compounds to a patient is required
- Familiar with the clinical trial design is preferred
- Experience working on supporting clinical trials in a hospital setting for oncology and/or other therapeutic areas is preferred
- Experience of the biologics drug dosing design and administration in various clinical development stages is preferred
- Up to 20% domestic and international travel
Janssen Research & Development, LLC. (6084)Job Function