Director, Method Development - Vaccines

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.

RESPONSIBILITIES

• You will independently plan, design, and conduct immunological assays including ELISA, NAb, genomic and virological assays on various scales and for different customers in a production lab environment with minimal supervision.
• Clearly communicate results and recommendations to colleagues, senior management, and customers in a timely manner, assisting in project decision-making.
• Participate in the transfer of processes, technology, and assays to/from internal and external collaborators and Sponsors.
• Demonstrated ability to train scientists in ligand binding assays, cell culture genomic and virologic assays. Support Scientists to troubleshoot, modify and re-optimize current assays.
• Develop methods including sample preparation, analytical method execution, definition of analytical instrumentation, data processing requirements, writing standard procedures/protocols, reports.
• Design and execute method qualifications and validations for new analytical method.
• Coordinate transfer of analytical method to the production laboratory, inclusive of initial training.
• Design and complete bioconjugation and characterization of critical reagents as needed for the new immunogenicity methods.
• Use JMP or other programs for design and analysis of development data, manage  data in LIMS.
• 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.
• Maintain a detailed awareness of industry guidance and standards for assay validation and performance and maintain current knowledge of advancing technologies and propose their applications to ongoing projects.
• Participate in scientific meetings and produce original peer-reviewed publications. Perform research and development activities to support new assay development and assess new technologies or formats.
• Oversee daily management of intra- and inter-organizational relationships to ensure timely completion of projects in accordance with customer specification.
• 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, including Good Clinical and Good Laboratory Practices.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Advanced understanding of ligand binding immunoassays and analytical instrumentation for
• chromogenic ELISA, chemiluminescence, fluorescence and electrochemiluminescence (MSD) assays.
• Experience in neutralizing antibody (NAb) assay development and execution preferred. This includes
• expertise in developing, maintaining, and banking cell lines and experience developing and validating
• cell-based assays.
• Experience in genomic method such as PCR utilized for the quantitation of pathogens or vaccine vectors.
• Experience in virological methods such as quantitative cultures is preferred.
• Experience in laboratory automation and liquid handling systems.
• Understanding of all routine laboratory procedures.
• Demonstrated experience in writing technical reports and 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 documentation.
• Ability to provide verbally communicated or draft procedures.
• Demonstrated ability to train staff of various skill levels.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• PhD with 4 years of regulated immunoassay experience preferred or bachelor’s degree in Biology/Chemistry/Biochemistry or a related field with 10 years of experience or equivalent combination of education, training, and experience in GLP laboratory environment.
• Minimum of 3 years supervising a team.

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.