J&J Family of Companies Pharmacist (Part-Time) in United States
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Pharmacist (Part-Time), that can be located in Malvern, PA or remotely within the U.S.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The successful candidate will work in the Biotherapeutics Drug Product Development (DPD)department. The candidate will help develop, design and perform formulation development and characterization in support of formulation and clinical dose preparation and administration of vaccines, mAb and other biological drug products.
• Collaborate with DPD Formulation Scientists, Global Trial Mangers, Clinical Physicians, Study Managers and Pharmacists to ensure that the drug product preparation and administration can be flawlessly executed at clinical sites for Phase 1 to Phase 3 clinical studies
• Participate in cross functional meetings with clinical scientists, pharmacists, nurses and physicians to ensure harmonization of drug delivery to the patients.
• Assist in review of phase 1-3 clinical protocols.
• Investigate dose preparation and/or delivery issues at clinical site collaborating with internal clinical and quality teams.
• Assist scientists and clinicians by identifying materials of construction of ancillaries used in the clinics. Suggest substitutions as needed.
• Lead or participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions and successfully resolve problems with suppliers, methods, project issues and deviations.
• Write/review pharmacy manual instructions and answer queries from the clinics regarding the dose preparation and administration procedures.
• Design studies to understand how the drug product interacts with the product contact material surfaces during dosage preparation and delivery of oncolytic viruses and other biologic drug products.
• Prepare documents for regulatory filings (IND, IMPD, BLA, MAA) and internal company use. Design experiments and provide relevant data to support responses for regulatory agencies minor deficiency letters.
• PharmD with 5-10 years’ experience in hospital pharmacy is required.
• Clinical trial experience in hospital pharmacy is required.
• A strong understanding on drug compounding and delivery is required.
• Familiarity with Good Clinical Practices and Good Pharmacy Practices is required.
• Familiarity with USP 797 and USP 800 is required.
• The ability to develop, document and analyze experiments that significantly contribute to process and material knowledge is required, including discerning and communicating testing outcomes effectively with cross-functional teams.
• Technical writing skills, including the ability to maintain high quality documentation and prepare reports, SOPs or other technical reports is required.
• Familiarity with a variety of compendial references including United States Pharmacopeia 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.
North America-United States
Janssen Research & Development, LLC (6084)