Scientist II

Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

* 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.

* Identifies the key elements of a situation and any gaps and inconsistencies in data. Makes rational judgements from available information and analysis.

* 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.

* 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.

* Other duties as assigned.

* Travel (approximately <5%) domestic and/or international.

* 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 little direct supervision.*

* Develops, qualifies, and validates a variety of immunological, biochemical, and cell-based methods with little direct supervision for supporting preclinical and clinical studies following applicable GXP guidelines.*

* 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.*

* Prepares reagents, buffers, solutions and solvents in accordance with SOPs, methods and/or Sponsor instructions.

* Trains on, employs and maintains routine operation, maintenance and theory of instrumentation and software systems.

* Manages and keeps current all training requirements.

* Follows SOPs and relevant compliance regulations in regards to safety procedures, documentation, and scientific responsibility.*

* Responsible for review and transformation/regression of results and data comparison against method acceptance criteria, methodology and other relevant direction documents.*

* Analyzes data and interprets results with input from senior staff but with expectation to develop increasing competency for independent delivery.*

* Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment.

* 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.*

* Must make and document scientific observations and identify and solve problems in experimental designs independently.

* Provides timely review of calibration/maintenance, reconstitution and protein processing data and notebook documentation.

* Keeps manager and Project Leaders informed of study status, technical problems and other issues which impact the laboratory.

* Responsible for initiation and timely completion of work assigned and assists in meeting project and study goals.

* 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.

* The desire and the ability to document results of test samples that include performing statistical analyses, identifying repeats or next tier analysis needs based on SOPs and other guiding documents.

* 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.

* Reads, analyzes and interprets, and writes common scientific and technical documents such as maintenance instructions, procedure manuals, scientific reports and correspondence.

* The ability to be the technical subject matter expert, SOP owner and qualified trainer on laboratory procedures.

* The capability to perform statistical analysis and interpretation of data.

* Effectively interfaces with other Scientists, Managers, Project Leaders, other members of the bioanalytical team, Sponsors and at scientific meetings.

* Follows standard policies and procedures to be able to present unsolicited ideas to supervisors for process improvement and to foster an environment of continuous innovation.

* Interacts with internal and external colleagues on routine and/or specific milestones of a project to ensure timelines are met.

* Collaborates effectively with fellow project members following priorities, checkpoints and timelines in support of ICON and Sponsor objectives.*

* Designs, directs and participates in equipment (and software) validations/calibrations/maintenance as necessary.

* Plans daily, weekly and monthly activities based on goals and timelines established by supervisor for scheduled projects.

* 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.

* The ability to determine repeat dilutions (where applicable).

* Associate's degree in science related field and prior directly relevant experience will be considered.