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Scientific Associate III
Ref No.: 18-23011
Location: Irvine, California
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.

Technical Responsibilities:
  • 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.

  • 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 Responsibilities:
  • Obtain necessary chemical reagents, reference standards and other components from appropriate sources, and prepare buffers and stock solutions of chemicals as needed.
  • Maintain laboratory equipment and instrumentation.
  • Perform all activities per applicable safety 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 and Experience:
  • 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.

Essential Skills and Abilities:
  1. Laboratory experimental skills and knowledge of scientific principles, techniques, and instrumentation employed in pharmaceutical formulation and analysis
  2. Strong oral and written communication skills
  3. Able to follow operating guidelines and adhere to Client's safety policies
  4. Strong interpersonal and team-work skills
  5. Good organization and planning skills
  6. Able to analyze and interpret data and troubleshoot experimental problems
  7. Strong sense of urgency and ability to operate under strict time constraints