Clinical Operations

  • location: Irvine, CA
  • type: Contract
  • salary: $32.69 - $38.46 per hour
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job description

Clinical Operations

Scientific Associate III

Wet laboratory skills and HPLC experience are essential. Prior experience with formulation development and analysis of complex drug delivery systems is preferred. Knowledge of basic statistics (hypothesis testing, regression analysis) and design of experiments is preferred. The ideal candidate will have prior pharmaceutical industry experience in the development of polymer-based parenteral sustained release formulations.

Job Summary

Plan and perform a variety of project-oriented formulation and analytical work assignments to support early-stage pharmaceutical product development. If assigned, represent department in CMC teams, actively contribute to team strategies and collaborate with cross-functional groups to meet drug development milestones with guidance from supervisor. Develop formulations and analytical methods with minimal supervision. Analyze and troubleshoot results with minimal guidance. Ensures laboratory operational capability by following current SOPs, proper maintenance of laboratory equipment and instrumentation. Document all experiments, results, and conclusions promptly and accurately. Provide guidance to junior staff as appropriate. Participate and contribute at group and project meetings as required. Contribute to publications such as department guidelines, technical reports, regulatory documents or scientific papers. Attend and present in seminars as required.

Job Responsibilities

Technical

  • Independently perform a variety of project-oriented work assignments (e.g., perform formulation development and associated analytical experiments, organize data, and analyze/record/report results and conclusions of experiments) to support the development of parenteral sustained release drug products. Design experiments with minimal supervision to meet the project objectives and timelines.
  • If assigned, represent department and actively participate in CMC sub-team(s) and contribute to team strategies with guidance from supervisor; provide high quality and well-interpreted data, and collaborate with other functional areas to solve technical problems and meet project development milestones.
  • Develop analytical methods with minimal supervision, execute associated laboratory experiments, and critically evaluate and analyze analytical data generated.
  • Troubleshoot any poor quality data and instrument performance issue with minimal guidance.
Documentation

  • Maintain and complete all required documentation including logbooks, lab notebooks, and analysis records in a timely manner.
  • Participate and contribute at group and project meetings as required (e.g., prepare and present results and conclusions to project sub-teams).
  • Contribute to publications such as department guidelines, technical reports, scientific papers, and regulatory documentation.
General Laboratory

  • Obtain necessary chemical reagents, reference standards and other components from appropriate sources.
  • Maintain laboratory equipment and instrumentation.
  • Perform all analytical activities per applicable safety guidelines and departmental guidelines
Scientific Excellence

  • Exercise sound scientific judgment in the evaluation of data.
  • This position requires accuracy, precision and thoroughness under strict time constraints.
  • Demonstrate efforts to improve the standard of all aspects of scientific work by showing initiative and leadership in the laboratory, learning new techniques, demonstrating problem solving ability and attention to detail.
  • Maintain current knowledge and skills by keeping informed through reading the literature, attending related seminars, and presenting at department meetings when required.
Education & Qualifications

  • BS or MS degree in chemistry, chemical engineering, pharmaceutics, or related scientific discipline.
  • At least three years of relevant experience in formulation development or analytical sciences is required.
  • Experience with use of HPLC, GC, and other advanced analytical instrumentation, Empower or other chromatography data acquisition systems, experimental procedures and sample preparations, and skills in using and troubleshooting of common laboratory instrumentation are essential. Prior experience in the development of polymer-based parenteral sustained release formulations is preferred.
  • Laboratory experimental skills and knowledge of scientific principles, techniques, and instrumentation employed in pharmaceutical formulation and analysis
  • Strong oral and written communication skills
  • Able to follow operating guidelines and adhere to Allergan safety policies
  • Strong interpersonal and team-work skills
  • Good organization and planning skills
  • Able to analyze and interpret data and troubleshoot experimental problems
  • Strong sense of urgency and ability to operate under strict time constraints
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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