Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
The Associate Research Investigator, Bioanalysis is the senior level scientific position and acts as an authoritative resource regarding the proper procedures and techniques required for scientific and project related matters. Demonstrate a high level of responsibility for the conduct of projects and play an active role mentoring and guiding junior members of the scientific team. Act as the primary point of contact for Q2 Solution's external customers, providing exceptional customer service while ensuring that all work meets Q2 Solution's scientific standards, continually seeking out better ways to plan and execute projects. Provide a strong leadership presence throughout the organization driving quality science and process improvements.
- Can act as the designee of the Director of Bioanalysis.
- Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.
- Provide scientific leadership through all stages of assays including method development, validation and sample analysis.
- Maintain a strong leadership presence throughout the organization by driving scientific quality, process improvement and automation initiatives.
- Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
- Work with the customer to resolve sample discrepancies.
- Monitor the progress of all assigned projects and alert management if work falls behind schedule.
- Provide regular project status updates to management.
- Participate in weekly scheduling and revenue update meetings and provide updates on project progress.
- Prepare validation and sample analysis plans.
- Review data (run binders, data tables, etc) for regulatory compliance and scientific quality.
- Address issues from QC and QA review for run binders.
- Conduct thorough investigations of all failed runs.
- Lead method troubleshooting investigations.
- Assemble group of pertinent technical resources and write up investigation report.
- Prepare corrective and preventative action plans (CaPas) for assigned projects.
- Provide leadership for Technical Writing and QA to ensure projects are completed on schedule.
- Review validation and bioanalytical reports for completeness.
- Host customer visits and lead scientific and business discussions.
- Visit customer sites to discuss ongoing projects and future business possibilities.
- Work with business development staff to prepare quotes for assigned customers.
- Work towards designing and implementing process improvement initiatives.
- Approve validation experimental designs.
- Prepare data for external presentations.
- Ensure projects are archived in accordance with Q2 Solution's SOP.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Proven experience with immunological methods, in particular, anti-drug antibody ligand binding assays.
- Expertise in developing, maintaining and banking cell lines.
- Experience developing and validating cell-based assays is required.
- Experience with neutralization assays such as Proliferation, ADCC or CDC preferred.
- Demonstrated ability to train scientists in cell culture and bioassays.
- Provide technical oversight including technology transfers, atypical results investigations, technology transfers, and proposal development.
- Assures good documentation and technical execution practices are consistent with industry standards, company and customer SOPs, including the GLPs.
- Requires a depth of understanding of one of more of immunology, cell biology, molecular biology or biochemistry.
- Experience with software for data analysis or other statistical analysis software (e.g. JMP) is essential.
- Excellent oral and written communication skills.
- Proactive project management approach, with open communication lines.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Ph.D, with 2+ years' experience preferred or BS/MS with 6+ years' experience or equivalent mix 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.
- 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'
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
Job ID: R1063571