Scientist, Biotransformation, DMPK

Location
South San Francisco, CA
Posted
Oct 29, 2019
Ref
1914305
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Drug Metabolism and Pharmacokinetics (DMPK) department at Theravance BioPharma is seeking a Scientist to conduct and manage biotransformation studies in support of drug discovery and development programs.   

The successful candidate will determine biotransformation pathways for Theravance Biopharma discovery and development molecules from a variety of in vitro, preclinical, and human ADME studies to elucidate the metabolic fate and clearance pathways/mechanisms of candidate molecules. The candidate will design study protocols, conduct studies, review data and assess the need for additional experiments/analysis; finalize reports and author ADME reports in support of IND/NDA submissions.

The successful candidate will exhibit an energetic and innovative approach to problem solving. Strong communication/interpersonal skills with a desire to work in a fast-paced, flexible and dynamic environment is required.

Duties and Responsibilities

  1. Design, conduct and manage the execution of biotransformation studies for multiple research and development programs.
  2. Utilize HPLC and LC-MS-MS to profile and identify metabolites from a variety of in vitro and in vivo matrices. Isolate and structurally characterize metabolites.
  3. Manage various CROs for outsourced preclinical and clinical ADME related studies including sourcing of radiolabelled standards and AMS sample analysis.
  4. An ability to employ various techniques including CYP bio-culture incubations, chemical synthesis and chemical derivatization, in order to generate and elucidate metabolite structures is highly desirable.
  5. Represent DMPK on multi-disciplinary project teams as required (including data analysis, study documentation/reporting and presentation) while providing strategic direction to chemistry plans.
  6. Authoring Scientific Publications and ADME Reports in support of IND/NDA submissions

Qualifications

  • Applicants should possess a PhD in Chemistry/Biochemistry/Pharmaceutical Science with 0 - 4 years of relevant industrial experience.
  • Prior LC MS/MS experience with Thermo Q-Exactive/Orbitrap and X-Calibur/ Mass Metasite software is highly desirable
  • Prior experience authoring relevant regulatory documents (IND/NDA) is desirable.
  • This individual is also expected to be highly organized, a team player, enthusiastic about drug discovery, and possess strong communication and leadership skills.