Manager, Immunoassay Vaccines Development

JOB OVERVIEW

As a Manager Immunoassay method development, you will be responsible for the development of bioanalytical methods to support immunogenicity testing by applying your expertise in ligand binding assays, and immunological techniques. Your contributions to this platform of testing will support multiple modalities across the spectrum of drug development.

RESPONSIBILITIES

• You will independently plan, design, and conduct immunological assays including ELISA, multiplex immunoassays (Luminex and Meso Scale Discovery platforms) 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, and bioassays. Support Scientists to troubleshoot, modify and re-optimize current assays.
• Assist the Scientists with lab work scheduling, including assay development, qualification, validation, and clinical testing.
• Develop methods including sample preparation, ligand binding approaches for the detection and quantitation of vaccine induced immune responses.
• Coordinate application of validated methods to sample analysis.
• Design and complete bioconjugation and characterization of critical reagents used to build ligand binding assays.
• Use JMP or other programs for design and analysis of development data, manage bioanalytical 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.
• Manage/mentor a team of up to four junior scientists.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Advanced understanding of ligand binding immunoassays and analytical instrumentation for chromogenic ELISA, chemiluminescence, fluorescence and electrochemiluminescence (MSD) assays.
• Experience with developing methods to support immunogenicity to gene delivery vehicles and transgene products is preferred.
• Experience in laboratory automation and liquid handling systems.
• 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 documentation.
• Ability to provide verbally communicated or draft procedures.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• PhD with 4 years of regulated bioassay experience preferred.
• Bachelor’s degree in biology/Chemistry/Biochemistry or a related field with 6+ years of experience.
• Or equivalent combination of education, training, and experience in GLP laboratory environment.

Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $98,400.00 - $147,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.