Nature and Scope

The R&D intern will assist in the day-to-day operations of the Clinical PK/BE function, including but not limited to, Project relevant literatures review, organizing the internal folders, support departments efforts in the preparation and improving standard operating procedures, data analysis methodologies. Reviewing study reports, status updates and other project development activities.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Assist PK/BE team in reviewing literature and summarizing important information.

• Learn and inform novel research methodologies in pharmacokinetics and bioequivalence studies.

• Assist PK-BE team in organizing and maintaining project specific folders.

• Provide hands-on support to PK/BE data analysis and summaries.

• Review and summarize Bioanalytical methods and study data.

• Research and adopt novel biostatistics methodologies relevant for in vitro, in vivo bioequivalence conclusions.

• Prepare manuscripts and in -house presentations.

• Assist R&D, RA, and CQA colleagues on support requests.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• P3/P4 Pharm.D. or Ph.D. student in Pharmaceutical Sciences or Bioanalytical, quantitate systems pharmacology.

• Pre-med or Medical student with interest in Early stage Clinical Development or Pharmaceutical product development.

• Completed at least one semester course work in Pharmacokinetics, Pharmacotherapy or Analytical chemistry, Biology, Chemistry, or Biostatistics.

• Knowledge in GMP/GLP regulations.

• Insight in using Phoenix/WinNonlin, R/R-studio, SAS and other data analysis programs.

• Attention to detail and able to follow instructions and operating procedures.

• Excellent organizational, interpersonal, written and oral and communication skills required.

• Proficiency in Microsoft Office Word and Excel is highly desirable.

• Ability to work overtime as needed.

Physical Environment and Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employee must be able to occasionally lift and/or move up to 50 pounds.