The primary objectives of this position are to manage the timely completion of bioanalytical projects in support of clinical and GLP-tox studies and to ensure the work done with high quality and in good compliance with current regulations. The primary function is to ensure successful development, validation, documentation, and implementation of bioanalytical methods and to ensure the successful completion of biological samples (e.g. plasma, urine, whole blood, feces, or tissues etc.) analysis and reporting of bioanalytical results in accordance with all applicable company SOPs and FDA or global guidance. Additional responsibilities may include on-site inspection of selected bioanalytical CROs and their adherence to appropriate FDA guidance and SOPs in conjunction with the QA group. This position will also assist in the conduct of human or animal ADME studies. See attachment
Knowledge and skills indicate the education level, previous experience, specific knowledge, skills and abilities necessary to meet the minimum requirements for this position.
Education level and/or relevant experience(s):
For the senior manager position in bioanalytical sciences in TMED, an MS/PhD degree in analytical chemistry, bioanalytical chemistry, pharmaceutical analysis or related fields with 6+ years for PhD, or 10+ years for MS, of industrial experience in the bioanalytical LC-MS/MS method development, validation and sample analysis under GLP regulations and with a minimum of 3 years of bioanalytical project management experience are required. Drug metabolism, PK, and Bioassay experience will be a big plus.
Knowledge and skills (general and technical):
Solid knowledge in the development and validation of bioanalytical LC-MS/MS methods. Extensive experience with HPLC, LC-MS/MS technology and associated computer softwares, along with a proven track record of successfully applying Client analytical concepts to the drug development process with an emphasis in dealing with the measurement of drug and its metabolite(s), and/or biomarkers in biological specimens such as plasma and urine etc. Extensive bioanalytical project management experience with the studies performed by selected external bioanalytical CROs.
Must be familiar with GLP and GCP regulations, compliance, and FDA and global guidance for Bioanalytical Method Validation. The selected individual must be self-motivated and innovative. It is expected that the individual will be able to work closely with CROs with moderate supervision. Excellent inter-personal skills are required since this individual will be working with scientists and managers from multiple disciplines as well as from different sites /labs. Customer and quality driven focus is a must. Work hours may include meetings scheduled outside of normal working hours. Occasional travel is required.