Associate Principal Scientist, Assay Development (Immunogenicity)
As an Associate Principal Scientist, candidate will be responsible for developing bioanalytical immunoassay or cell-based assays supporting PK/PD concentration and immunogenicity assessment. By applying expertise in ligand binding assays such as ELISA and ECLA, bioassay and immunological techniques to quantitate biotherapeutics and biomarkers and to characterize immune responses to biologics, candidate will turn hope into help by accelerating our partners' drug development programs. Contributions to this platform of testing will support multiple modalities across the spectrum of drug development in a custom-built state-of-the-art laboratory that includes bioanalytical, vaccines, genomics, anatomical pathology, and flow cytometry laboratories.
RESPONSIBILITIES:
• Responsible for performing complex assay/method development.
• Responsible for execution of assay/method development experiments.
• Establishes the assay/method procedure to ensure effective operational execution.
• Evaluates, recommends, and implements new technology and instrumentation.
• Leads complex technical projects and guide the work of junior staff.
• Works proactively across functions to identify opportunities for innovation and troubleshoot challenges to ensure effective delivery to the customer and deployment of the method.
• Applies knowledge to leverage opportunities to deploy method across multiple studies.
• Drives opportunities for process and operational efficiencies.
• Leads training initiatives to support continuous learning and development of lab staff.
• Maintains scientific awareness of overall developments in area of expertise based on current literature and application of new technologies and experimental techniques.
• Utilizes scientific awareness to bring innovative ideas for assay and method development.
• Contributes to scientific literature and conferences, internal reports, documents and communications including the writing and/or creation of abstracts, peer-reviewed journal articles, poster presentations, and marketing materials.
• Provides technical support for the maintenance and operational standards of laboratory equipment.
• Provides and disseminate meaningful data analysis and interpretation of experimental findings in acceptable laboratory formats.
• Provides project updates/reports of deliverables to project manager, as requested.
• Maintains laboratory notebooks under applicable regulatory standards and good documentation practices.
• Contributes to quality, safety and Six Sigma initiatives.
• May review laboratory notebooks.
• May present findings to a wide variety of audiences internal and external to Q2 Solutions.
• Follows all appropriate lab and company procedures and policies. Performs work in accordance with applicable regulatory requirements.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
Responsible for performing complex assay/method development.
• Responsible for execution of assay/method development experiments.
• Establishes the assay/method procedure to ensure effective operational execution.
Bachelor's Degree or equivalent combination of education, training, and experience.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
• Evaluates, recommends, and implements new technology and instrumentation.
• Leads complex technical projects and guide the work of junior staff.
• Works proactively across functions to identify opportunities for innovation and troubleshoot challenges to ensure effective delivery to the customer and deployment of the method.
• Applies knowledge to leverage opportunities to deploy method across multiple studies.
• Drives opportunities for process and operational efficiencies.
• Leads training initiatives to support continuous learning and development of lab staff.
• Maintains scientific awareness of overall developments in area of expertise based on current literature and application of new technologies and experimental techniques.
• Utilizes scientific awareness to bring innovative ideas for assay and method development.
• Contributes to scientific literature and conferences, internal reports, documents and communications including the writing and/or creation of abstracts, peer-reviewed journal articles, poster presentations, and marketing materials.
• Provides technical support for the maintenance and operational standards of laboratory equipment.
• Provides and disseminate meaningful data analysis and interpretation of experimental findings in acceptable laboratory formats.
• Provides project updates/reports of deliverables to project manager, as requested.
• Maintains laboratory notebooks under applicable regulatory standards and good documentation practices.
• Contributes to quality, safety and Six Sigma initiatives.
• May review laboratory notebooks.
• May present findings to a wide variety of audiences internal and external to Q2 Solutions.
• Follows all appropriate lab and company procedures and policies. Performs work in accordance with applicable regulatory requirements.
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. https://www.q2labsolutions.com/careers
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe
As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status