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Analytical R&D Associate MUST HAVE Pharmaceutical Industry Experience
Ref No.: 17-00257
Location: Irvine, California
Position Type:Contract
Start Date / End Date: 03/13/2017 to 12/22/2017

Project Description:
Independently plan and perform a variety of project-oriented analytical work assignments to support all stages of 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 and validate analytical methods with minimal supervision. Independently prepare method validation protocol/investigation plan, and execute validation work under cGMP practices. Analyze and troubleshoot results with minimal guidance. Ensures laboratory operational capability (for both cGMP and development laboratories) by following current SOPs, proper maintenance of laboratory equipment and instrumentation. Document all experiments, results, and conclusions promptly and accurately. Provide guidance and training to Scientific Associate I and II. 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 analytical work assignments (e.g., perform analytical experiments, organize data, and analyze/record/report results and conclusions of experiments) to support the development of drug substances and 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 and validate phase appropriate analytical methods with minimal supervision.
  • Prepare method validation plans/protocols and reports, execute associated laboratory experiments, and critically evaluate and analyze generated analytical data.
  • Perform analytical testing of a variety of drug substance and drug product samples with error free results in a timely manner.
  • 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.
  • Prepare methods, qualification reports, investigational report, validation protocol / investigation plan, and validation report as required.
  • 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, or scientific papers.

General Laboratory Responsibilities:
  • 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, departmental guidelines, and cGMP requirements.

Scientific Excellence:
  • Maintains knowledge of cGMP compliance through internal and external training.
  • 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.
  • Provide guidance and training to Scientific Associate I and II.
  • Maintain current knowledge and skills in all facets of analytical sciences by keeping informed through reading the literature, attending related seminars, and presenting at department meetings when required.

Required Skills:
  • BS degree with 5+ years or MS degree with 3+ years of analytical development experience in pharmaceutical R&D.
  • Experience with use of HPLC, GC, and other advanced 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.
  • Strong knowledge of analytical techniques and instrumentation, data processing software skills.
  • Strong oral and written communication skills.
  • Excellent experimental skills
  • Able to follow operating guidelines and adhere to Client safety policies. Act as a role model to Scientific Associate I and II.
  • Strong interpersonal and team-work skills. Able to provide some guidance and training to Scientific Associate I and II.
  • Good organization and planning skills.
  • Able to analyze and interpret data and troubleshoot experimental problems.

This 9+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Dexter: