Associate Principal Scientist Assay Development

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.

JOB SUMMARY

This Associate Principal Scientist builds on past experience, skills and personal attributes of an accomplished bioanalytical scientist, and requires the ability to act independently with little or no guidance. The position involves applying analytical skills to assist in the development and implementation of profit-generating PK/Immunogenicity/Biomarker assays. An advanced understanding of ligand binding assays and diverse analytical  instrumentation, development/validation of methodology, biological sample preparation, interpreting of data, interacting with clients to share development and progression, and working to objectives/timelines are integral to this position.

RESPONSIBILITIES

• Work under the general guidance of a Scientific Director to develop and validate new bioanalytical approaches pertaining specifically to biomarker and biotherapeutic assays for disease mechanism investigations and support of drug development studies
• Work with key clients to implement this service in accordance with their expectations
• Develop methods including sample preparation, ligand binding approaches for the detection and quantitation of identified biologic, anti-drug antibodies and biomarker targets.
• Validate associated methodologies to a fit-for-purpose extent
• Coordinate application of validated methods to sample analysis
• Use JMP or other programs for design and analysis of development data, manage bioanalytical data in LIMS
• Communicate with clients regarding progress on scientific and operational objectives
• Work with management to set work plans, goals and metrics to build this service
• Prepare and presents project data and supporting information. Contributes to and reviews technical reports
• Attends scientific meetings and client visits to promote the large molecule bioanalytical business
• Train less experienced scientific co-workers, when necessary, to support growth of Immunoassay service
• Validate methods to regulatory (GLP) standards
• Oversee the application of the validated methods to routine sample analysis
• Oversee daily management of intra- and inter-organizational relationships to ensure timely completion of projects in accordance with customer specification
• Provide frequent communication of project status with clients
• Prepare and make external presentations of Immunoassay capabilities to clients and prospective clients
• Apply analytical skills to assist in the development and implementation of profit-generating assays
• Comply with all applicable regulatory standards, Guidances, including Good Clinical and Good Laboratory Practices.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Understanding of ligand binding immunoassays and analytical instrumentation for chromogenic ELISA, chemiluminescence, fluorescence and electrochemiluminescence (MSD) assays. Knowledge of biosensor binding assays such as the Octet and cell-based assay development.
• Understanding of all routine laboratory procedures
• Understanding of development/validation of methodology
• Understanding of wet laboratory workflows and an eye for efficiency and innovation in delivery.
• Ability to interact with clients, and work to objectives/timelines
• Excellent attention to detail and communication skills
• Ability to maintain clear and efficient method development documentation
• Ability to provide verbally communicated or draft procedures
• Advanced understanding of ligand binding assays and analytical instrumentation, development/validation of methodology, biological sample preparation, interpreting of data
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s Degree in Biology/Chemistry/Biochemistry or a related field with 7 years’ progressively responsible related experience; or equivalent combination of education, training and experience in GLP laboratory environment.

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 workday_recruiting@iqvia.com to arrange for such an accommodation.