JOB DESCRIPTION – Senior Associate Scientist, Pharmacokinetics, Spring House PA
Janssen Research and Development, a member of the Pharmaceutical Companies of Johnson & Johnson is recruiting for a Senior Associate Scientist, Pharmacokinetics group, located in Spring House, PA, USA.
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 L.L.C. discovers and develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurological disorders, gastroenterology, oncology, infectious disease, pulmonary hypertension, hematology, metabolic disorders, immunology disorders, ophthalmology, and reproductive medicine.
We are looking for a Senior Associate Scientist, based out of Spring House PA, in the pharmacokinetics (PK) group to act as the kineticist for PK and toxicokinetic (TK) studies. As a member of the PK team, you will be responsible for the design, analysis, and interpretation of PK and TK studies. You will collaborate with the contracting group, the Drug Metabolism and Pharmacokinetics (DMPK) project leaders, and the Contract Research Organizations (CROs) to generate study outlines for scheduling and drafting work orders.
Additionally, you will manage the study protocols by collating comments and ensuring revisions in a timely manner, and work with partners to ensure compound shipment to the CROs. For internal studies, you will be responsible for generating the PK/TK parameters and report. For external studies (where the CRO provides data output and report), you will be responsible for reviewing the data and report for accuracy. You will be responsible for preparation of data in the FDA SEND (Standard for Exchange of Nonclinical Data) format, when applicable. The ability to collaborate within cross-functional teams and represent the PK group during study review meetings will be necessary.
The kineticist plays a critical function in the development machinery at Janssen, acting as a collaborator working closely with DMPK project leaders to plan experiments and drive study cycle times that are critical for maintaining a competitive advantage.
- A BS or MS in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry or related field, with 3+ years of relevant industry experience
- Design of in vivo PK and TK studies and ability to understand project relevance
- Generating PK parameters using Phoenix WinNonLin or other pharmacokinetic analysis software
- Basic knowledge of PK and toxicology
- Good communication skills relevant for an email-heavy work function
- Ability to work with multiple stakeholders residing internally and in CROs
- Animal physiology, formulations, and in-life study knowledge and experience
- Project management experience
- Understanding of drug development process
- Understanding of the SEND requirements for data submission
- Understanding of GLP requirements
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.