• Expertise with various analytical techniques for the measurement of biomarkers from complex matrices. Demonstrated experience in development of quantitative analytical bioassays for the measurement of neurotransmitters, lipids, proteins, peptides or antibodies is required.
• As a Staff Scientist in the Drug Metabolism and Pharmacokinetic (DMPK) Translational Research group at Takeda, you will participate in drug discovery through development and execution of quantitative biomarker assays to enable and support discovery translational research.
• In this position, the individual is expected to demonstrate strong written and oral communication, technical proficiency, scientific creativity, and to think and work independently with minimal guidance. The primary responsibility of this position is to provide scientific and technical leadership in quantitative biomarker assay development and execution. The role consists of laboratory-based activities as well as providing input into research strategies to matrix teams and/or program teams and will collaborate with global Takeda sites for the advancement of the portfolio, translational medicine and pre-clinical biomarker efforts for programs to IND filing.
• Support drug discovery and early development programs by providing relevant scientific and strategic input with respect to quantitative analytics of biomarkers, PK-PD, and translational research strategy.
• Design, execute, and report key biomarker data to support compound progression and translational research strategy for programs from target loading through early clinical development
• Work with project teams to address biomarker strategy through candidate selection
• Collaborate with biology, pharmacology, and modeling and simulation colleagues to design and conduct PK/PD and/or efficacy studies to support translation and clinical dose setting
• Evaluate and develop biomarker assays via LC-MS/MS technologies, ligand-binding assays, or other appropriate assay systems
• Work closely with department colleagues to coordinate work for project teams
• Is responsible for ensuring strong alignment and interfaces with DMPK groups across US affiliates and Japan Discovery and Development
• Keep an accurate notebook according to company policy
• Communicate with colleagues effectively
• Follow company safety procedures
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• PhD with post doc in Analytical Chemistry/Pharmaceutical Science/Biochemistry/Protein Chemistry or related coursework with 0-3 years of relevant industry experience OR MS/MA with 10+ years OR BS/BA 12+ years industry experience.
• Experience in developing fit-for purpose biomarker assays for the measurement of proteins, peptides, and antibodies
• Expertise in development of quantitative analytical bioassays from complex matrices is required
• Thorough understanding of application of biomarkers to understanding exposure-effect relationships.
• Ability to identify and implement (where and when appropriate) new technologies for the advancement of quantitative biomarker analytics
• Must be able to manage assay development and analysis queues and timelines
• Knowledge of drug discovery process, DMPK function and pharmacology is highly desirable
• Demonstrated ability to solve scientific problems creatively, effectively and independently
• Demonstrated ability to work within a matrix and team environment
• Excellent oral and written communication skills
• Manual dexterity required to operate standard laboratory and office equipment
• Carrying, handling and reaching for objects
• Exposure to hazardous/toxic/dangerous chemicals
• Prolonged standing and/or sitting.
• May travel to various domestic conferences or client sites, including overnight trips
• Some international travel may be required
• Requires a minimum of 2% travel