Principal Scientist, Methods Development

Location: Austin, Texas, United States

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Requisition Number: 1690

Position Title: Principal Scientist, Method Development

External Description:

SUMMARY:  A Principal Scientist, Method Development adapts existing procedures for new objectives, transfers procedures, and develops complex procedures with no oversight.  They have demonstrated scientific leadership and become recognized as a scientific leader.  Principal Research Scientists regularly contribute to literature and building Worldwide intellectual property.  They are capable of leading interdisciplinary project teams.   

RESPONSIBILITIES:

Tasks may include but are not limited to:

  • Develop complex bioanalytical methods for client and Worldwide owned assays
  • Develop new processes to improve efficiency and quality
  • Train staff in new methods, processes, and technologies
  • Conduct research studies including drug metabolism studies     
  • Evaluate the potential to automate work practices and, whenever possible, implement it
  • Able to quickly identify liabilities of an assay using a standardized testing procedure
  • Operating Procedures, Employee Handbook, and Health and Safety Manual
  • Transfer and optimize client-owned assays
  • Adapt existing assays for new objectives
  • Validate assays, as needed
  • Work closely with others to ensure that methods are effectively validated and used
  • Evaluate and implement new technologies
  • Perform routine chemical assays with consistent accuracy and precision
  • Produce technical documents, publications, posters, reports or communications
  • Prepare standard operating procedures
  • Represent Worldwide with external poster or podium presentations
  • Understand and apply regulatory guidelines when applicable
  • Document promptly and clearly procedural processes
  • Maintain instrumentation to the highest standards of performance
  • Participate in investigations as a technical expert and determine assignable causes for unexpected events
  • Review data recognize and report inconsistencies
  • Work independently, when required, to conduct and plan laboratory work
  • Provide regular oral and written communication of work; interface with clients
  • Follow Worldwide’s safety guidelines and perform tasks in a safe manner
  • If assigned, function as a lab monitor or safety committee member
  • Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

    OTHER SKILLS AND ABILITIES:
  • Lead or represent on project teams focused on a narrow area of expertise
  • Established knowledge of separation science
  • Established knowledge of mass spectrometry
  • Ability to read, execute, and understand complicated and detailed instruction and technical literature to plan, perform, and direct laboratory activities
  • Excellent attention to detail
  • Established computer knowledge (i.e. analytical software validation)
  • Advanced knowledge of industry regulations in bioanalytical method validation; FDA and EMA
  • Expanding knowledge of industry regulations in drug development (i.e. MIST, BE/BA)
  • Established knowledge of quantitative analysis and experience with its application to biological samples
  • Must be able to work with constant interruptions
  • Familiarity with corporate policies, goals, and objectives; normally acquired after three months of on-the-job exposure to Worldwide operations
  • Familiarity with various divisions of Worldwide; normally acquired after 1-year on-the-job training

REQUIREMENTS:
 

  • Ph.D., or postgraduate degree, with a scientific focus preferred
  • Bachelor’s degree, with a science discipline, and 12 or more years of relevant work experience required

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City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Principal Scientist, Methods Development

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Austin, Texas US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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© Worldwide Clinical Trials 2019

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.