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Laboratory Manager (Analytical Development)

Oakland-Fremont-Pleasanton Metro Area, California

Post Date: 06/29/2017 Job ID: JN -062017-19420 Industry: Analytical Chem - Scientific
  • This key role in provides scientific leadership and laboratory support for all analytical testing to support Fermentation and Purification studies, QC, Manufacturing deviation investigations, and Process Characterization studies.
  • This position drives experimental design for laboratory-based testing to either develop new methods/processes or to improve existing methods/processes.
  • Works closely and interacts with internal and external customers to provide the appropriate level of support.
  • A key focus for the bioanalytical lab manger is identifying and implementing process analytical tools and technologies to improve process understandings and drives innovation, efficiency and productivity in the lab.
  • Manages the laboratory budget and prepares the annual budget forecast and capital equipment requests.
  • Manages a team of Associates performing laboratory-based studies to support process characterization, process improvement or investigations into process-related deviations in either:
    • Fermentation (microbial and mammalian fermentation, scale up, fed batch, culture analysis)
    • Purification (recombinant protein purification, IEC, GFC, RP-HPLC, HIC and other process improvements)
    • Analytical Methods (HPLC, SEC, DLS, Mass Spectroscopy, SDS PAGE, Silver Stain, Western Blot, ELISA, for in-process and release testing)
  • Provides leadership, motivation and career development of laboratory staff
  • Acts as the key point of contact for study owners for related studies and be the group representative in team meetings
  • Manages the laboratory budget and preparing the annual budget forecast and capital equipment requests
  • Prepares CARs and all other required forms for laboratory equipment purchases and facilities modifications/improvements
  • Identifies staff that perform each study according to required number of fermentations, purifications or analytical tests and complexity of the study
  • Maintains a monthly experimental schedule for the Laboratory running whenever possible at a capacity of >80%
  • Review and approves Technical Protocols, Method development and Qualification reports
  • Ensures timely review of all data supporting technical studies.
  • Ensures laboratory equipment and instrumentation upkeep which include troubleshooting, PM/calibration/qualification as needed
  • Ensures staff are on-boarded and compliant with required trainings
  • Communicates frequently with senior colleagues on project timing, progress and issues promptly.
  • Provides weekly and monthly progress reports to Director of TD.
  • Communicates with personnel from other Departments such as Facilities, Engineering Metrology/Calibration, Supply Chain Management, and Technical Services, to ensure laboratories are operational at least 48 weeks per year.
  • Capable of effective use of Microsoft Word, Excel and PowerPoint
  • Strong working knowledge of DOE approaches for experimental design
  • Extensive working knowledge of cGMP environments
  • Very strong ability to plan and coordinate complex studies involving multiple departments
  • Excellent written and verbal communication skills
  • 10+ years of experience with a Ph.D. in Analytical Development, Process Development environment in the biotechnology or diagnostics industry
  • Strong understanding of microbial and Mammalian derived recombinant protein processes and Analytical Testing of recombinant proteins and monoclonal antibodies is highly desirable.
  • At least 5 years previous experience managing a team of Associate Scientists
  • Previous experience developing budget forecasts would be advantageous
  • Experience working with design of experiments approaches and Process Analytical tools.
  • Ph.D. in Microbiology/Biochemical Engineering or related discipline

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