Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies is recruiting for a Scientist/Pharmacist, to be located in Malvern, PA. Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer.
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.
MAJOR DUTIES AND RESPONSIBILITIES TO INCLUDE:
Design and execute formulation development experiments for biologic drug candidates (including vaccines and monoclonal antibodies), including rational formulation design/selection plus characterization studies relevant to the stage of development. Studies include, but are not limited to, biophysical characterization, stability, composition selection and robustness and development of administration protocols.
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.
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.
Design and execute studies to understand how the drug product interacts with the product contact material surfaces during fill/finish manufacturing and during dosage preparation and delivery of oncolytic viruses and other biologic 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.
Clinical experience in hospital or community 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.
Knowledge and experience of biopharmaceutical formulation and process design is preferred; An understanding and experience in the application of various GXP and QbD concepts is preferred.
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.
Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, and particle methods) and biophysical techniques is preferred.
Familiarity with a variety of compendial references including United States Pharmacopeia Is preferred.