Scientist, Biotransformation, DMPK
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
- Design, conduct and manage the execution of biotransformation studies for multiple research and development programs.
- 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.
- Manage various CROs for outsourced preclinical and clinical ADME related studies including sourcing of radiolabelled standards and AMS sample analysis.
- 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.
- Represent DMPK on multi-disciplinary project teams as required (including data analysis, study documentation/reporting and presentation) while providing strategic direction to chemistry plans.
- Authoring Scientific Publications and ADME Reports in support of IND/NDA submissions
- 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.