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Immunoassay Method Development (Associate Principal Scientist)

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1225745

Descripción del trabajo

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. 

RESPONSIBILITIES

  • You will independently plan, design, and conduct immunological assays including ELISA, ECLA and NAb 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 and bioassays. Support Scientists to troubleshoot, modify and re-optimize current assays.
  • Develop methods including sample preparation, ligand binding approaches for the detection and quantitation of identified biologic, anti-drug antibodies and biomarker targets.
  • 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • PhD with 4 years of regulated bioassay experience preferred or 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.

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 such as proliferation, ADCC or CDC.
  • 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

PHYSICAL REQUIREMENTS

  • 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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.

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