Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
- Functional area technical expert in metID concepts, including study design, conduct and interpretation.
- Oversee or perform tasks associated with in vitro and in vivo metID studies.
- Design, interpret, implement, document, report, and oversee metID study packages in collaboration with junior-level staff, including analytical methods for analysis of metabolites, metabolic profiling, and MS and MS/MS data collection, using appropriate level of regulatory compliance.
- Troubleshoot and/or consult on more complex metID packages, including analytical method, metabolite profiling, metabolite identification, and broader study impact.
- Interpret MS/MS data and assign metabolite structures; mentor staff on metabolite assignments.
- Consult with clients, site personnel, external Quintiles divisions, and/or third party vendors on scientific issues/packages, scientific principles, or other aspects of metID studies
- Manage allocation of Metabolism resources, including project assignment and capacity management, as requested by Quintiles management.
- Provide direction, support, and policy development recommendations to Metabolism staff and Quintiles management team, as requested by Quintiles management.
- Provide supervision, technical training, guidance, and mentorship to lower level and new staff.
- Consult with clients to prepare relevant drug metabolism sections of global dossiers for regulatory submissions.
- Keep abreast of literature; interact with peers in the in vitro metabolism scientific arena, attend professional meetings.
- Contribute to continuous improvement initiatives to increase quality or services and operational efficiency.
- Ensure quality and timely delivery of the project deliverables to clients for multiple projects.
- Propose and evaluate new technologies, techniques, study designs or equipment.
- Assist management in implementing strategic initiatives and business development on drug metabolism.
- Perform other duties as assigned by Quintiles Management.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of drug metabolism processes, including analytical method development, metabolite profiling, metabolic processes, and structural determination.
- In-depth knowledge of laboratory equipment and instrumentation, with particular focus on MS instrumentation (MS and MS/MS data collection and basic interpretation; instrument trouble shooting).
- Responsible for overseeing performance of group personnel, including data interpretation/scientific innovation/scientific productivity
- Ability to establish and maintain effective working relationships with coworkers, management, and clients
- Recognized as an effective team member; modeling work on best practices; mentoring team members.
- Knowledge and ability to establish, implement, and evaluate good laboratory practices or other documentation standards for the broader organization.
- Good documentation skills; ability to manage and maintain complete and accurate records of experiments.
- Attention to detail and accuracy in work against milestones or goals.
- Ability to manage/oversee multiple tasks and projects
- Excellent written and oral communication skills
- Knowledge and implementation of safe laboratory practices
- Ability to critically evaluate data and lab processes; propose and implement new approaches
- Ability to oversee and mentor lower level and new staff
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- PhD in chemistry, biochemistry, or biology or related field and 5 years' relevant experience; or Master's Degree in chemistry, biochemistry, or biology or related field and 8 years' relevant experience or Bachelor's Degree and 12 years' relevant experience; or equivalent combination of education, training and experience.
- Work is performed in a laboratory environment, full manual dexterity and visual acuity required
- May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Use of keyboard requiring repetitive motion of fingers
- Regular sitting or standing for extended periods of time
- Occasional travel
EEO Minorities/Females/Protected Veterans/Disabled
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at email@example.com to arrange for such an accommodation.
Job ID: R1060512