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Research Associate III /Scientist I

Post Date:Aug 10, 2018Type:Full-Time/Part-Time
Start Date:8/10/2018Salary:
Location:US-CA-Newark Job Reference:18-06164

Job Description:
Senior Associate/Scientist I, Analytical Development
Newark, CA
Position Summary
This position will focus on analytical characterization activities in support of therapeutic protein development. Responsibilities will include development of new product specific assays as well as routine testing of in-process samples. Will work independently and serve as subject matter expert for their focus area, including leading method development, qualification, and technology transfer activities. The position will also perform routine testing and general support activities as needed to meet the goals of our companies’ development programs. 
Essential Duties
  • Regularly apply basic theory and principles from one’s technical expertise to develop, optimize, and transfer analytical assays for product characterization, lot release, and stability testing.
  • Coordinate and conduct routine testing support for other groups within our Development and Manufacturing Functions.
  • Perform routine instrument/equipment maintenance and calibration checks to ensure the proper function and compliant use.
  • Provide regular progress updates to manager and present data to internal and external audiences in a succinct and well organized manner.
  • Author test methods and development reports.
  • Serve as subject matter expert for at least one technical area and train other laboratory personnel on the use and maintenance of equipment.
  • Lead technical transfer of assays to and from contract test laboratories or to QC.
  • Plan experiments with limited manager oversight and work independently to achieve deliverables with minimal instruction.
  • Develop and implement laboratory policies for critical reagents, data management, organizational performance, and continuous improvement.
  • Maintain laboratory notebooks and forms consistent with Good Documentation Practices.
  • Maintain adequate supplies of laboratory reagents and coordinate biohazard and chemical waste disposal.
  • Solid training in general laboratory practices (e.g., buffer preparation, sample dilution, micro-pipetting).
  • Experience in the development and optimization of assays for pharmaceutical characterization.
  • Experience in one or more of the following areas, including training and troubleshooting experience
    • Chromatography or capillary electrophoresis
    • Mass spectrometry
    • Immunochemical assays
    • Spectroscopy
    • Cell based assays
  • Working knowledge of cGMP practices and ICH guidelines.
  • Excellent written and verbal communication skills are required.
  • Excellent interpersonal skills with ability to efficiently function in a team-oriented environment.
  • Excellent planning and organizational skills with good documentation, record management habits, and attention to detail.
  • Ability to handle multiple projects and to demonstrate initiative and take accountability.
  • Flexible and adaptable to meet the needs of the organization.
  • Chemistry or Biological Science degree:  Bachelors with 8+ years, masters with 6+ years, or doctorate with 2+ years of experience in biopharmaceutical analytical development.
  • This is a senior technical position; level is dependent on experience and qualifications.

Contact Information
Name: Ryan Matlock

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