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Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
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Operates independently with a willingness to make decisions; projects credibility and makes a professional and positive impression on others; monitors progress and holds self and others accountable to contribution and quality.
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Identifies the key elements of a situation and any gaps and inconsistencies in data. Makes rational judgements from available information and analysis.
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As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
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Delivers high quality standards and strives for excellence; acts in a proactive, flexible and responsive manner to customer needs which may necessitate overtime and weekend work at times.
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To undertake other related duties as may be assigned.
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Travel (approximately 10%) domestic and/or international.
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Responsible to complete the day-to-day activities required to maintain the bioanalytical laboratory including responsibility for independently conducting validated assays on biological samples from pre-clinical and clinical trials for pharmaceutical and biotechnology projects requiring no direct daily supervision.
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Develops, qualifies, and validates a variety of immunological, biochemical, and cell-based methods with no direct supervision for supporting preclinical and clinical studies following applicable GXP guidelines.
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Responsible for review and transformation/regression of results and data comparison against method acceptance criteria, methodology and other relevant direction documents.
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Supports data input into laboratory information management systems including documenting receipt, entering and maintaining inventory of assay reagents, supplies and controls required for use in bioanalytical methods.
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Prepares reagents, buffers, solutions and solvents in accordance with SOPs, methods and/or Sponsor instructions.
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Trains on, employs and maintains advanced operation, maintenance and theory of instrumentation and software systems for automated liquid handling platforms, integrated instrument systems, plate readers or other instrument operation.
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Designs, directs and participates in equipment (and software) validations/calibrations/maintenance as necessary.
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Manages and keeps current all training requirements.
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Experience and depth of understanding of LIMS (or similar) systems, electronic notebook systems, instrument software applications and their integration.
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Follows SOPs and relevant compliance regulations in regards to safety procedures, documentation, and scientific responsibility and also presents unsolicited ideas to supervisors for process improvement and to foster an environment of continuous innovation.
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Makes detailed observations of experiments; record experimental data and maintains accurate and highly organized laboratory documentation including summaries; as well as performs peer review of peer records to create timely, accurate, legible, error-free lab records.
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Must make and document scientific observations and identify and solve problems in experimental designs independently.
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Provides timely review of calibration/maintenance, reconstitution and protein processing data and notebook documentation.
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Keeps Managers and Project Leaders informed of study status, technical problems and other issues which impact the laboratory.
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Advises and supports more junior scientists and the laboratory managers and Project Leaders when deviations or factors that may affect quality, accuracy and usefulness of the data occur.
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Documents results of testing that includes performing more complex statistical analyses such as cutpoint assessments, identifying repeats or next tier analysis needs based on SOPs and other guiding documents.
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Independently interprets data to solve practical problems and isolate variables in situations where troubleshooting problematic assays or unanticipated failures is required and proposes next steps including implementation of effective CAPA.
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Reads, analyzes and interprets common scientific and technical documents such as SOPs, maintenance instructions, procedure manuals, scientific reports and correspondence.
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Effectively interfaces with other Scientists, Managers, Project Leaders, other members of the bioanalytical team, Sponsors and at scientific meetings.
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Interacts with internal and external colleagues on routine and/or specific milestones of a project to ensure timelines are met. Demonstrates effective independent or team-based effort to formulate priorities, meet checkpoints and deliver timelines in support of ICON and Sponsor objectives.
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Responsible for initiation and timely completion of work assigned and assists in meeting project and study goals. Plans daily, weekly and monthly activities based on goals and timelines established by supervisor for scheduled projects.
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Participates in internal seminars and poster sessions, and local and regional scientific meetings in own field as necessary to continue professional development and to distribute such knowledge to colleagues.
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Supports and develops the scientific and technical capabilities of the function and the development of scientific staff including training/mentoring of scientists and other bioanalytical team members.
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Communicates effectively and creates comprehensive written and verbal/visual instruction that is applied to support of bioanalytical testing and reporting with attention to detail, strong organizational skills, the ability to multitask, and demonstrates effective interpersonal and communication skills.
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Proposes, evaluates, and implements new technology platforms for quantitative bioanalytical methods.
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Independently applies basic scientific principles, perform literature searches, attend scientific meetings, and keep abreast of relevant literature to support current work and develop additional bioanalytical capabilities.
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Directs interaction with bioanalytical team members, including presentation of data, critical review of data, preparation of assay summary reports as needed.
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Leverages scientific and pharmaceutical development knowledge and cross-functional experience to drive collaboration within ICON.
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Bachelor’s degree or local equivalent (scientific discipline is preferred).
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Master’s degree preferred.
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Manages time effectively to complete assignments in expected time frame.
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Demonstrates consistently good communication and interpersonal skills with peers, colleagues, management and Sponsors (where applicable).
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Effectively disseminates information with some guidance and exchanges information through written and oral communications.
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Ability to work independently on complex analysis.
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Demonstrates technical competency on all equipment, instrumentation and software interface used in bioanalytical testing support employing ligand binding and/or LCMS modalities.
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Performs instrument software configuration for application of bioanalysis and data transformation/regression.
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Maintains technical proficiency in the use of scientific instruments including meeting accuracy and/or precision requirements for bioanalytical methods and instrument calibration/maintenance/usage.
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Authors, reviews and/or revises policies, guidelines and SOPs and is a qualified trainer.
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Strong computer skills (Microsoft Word, Excel, JMP and Power Point) to allow efficient and effective use of instrumentation software, analytical LIMS and other ICON systems.
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Ability to undertake tasks with minimal supervision.
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Good organizational skills and excellent record keeping ability.
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Strong attention to detail.
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A minimum of 5 years’ experience successfully performing a scientist 2 or equivalent role
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