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PROCESS SPECIALIST, OPERATIONS TECHNICAL SUPPORT - BIOLOGICS

Job Field: Legal Jobs
Location: San Diego, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Position Overview
This position is supporting Operations Technical
Support, responsible for troubleshooting,
optimizing and resolving technical issues in
Operations or any areas needed when directed from
management.  This position is part of a team
supporting and improving the overall product
quality at Alere San Diego.
Organization Chart
Position reports to Director, Operations Technical
Support or Designee
Major Functions Objectives
1.  Spend 80% of time working in the lab
performing the following to support and improve
quality of product and process
      a.     Purification of proteins
      b.     Perform investigational work on large
scale process purification
      c.     Perform analysis using different
analytical techniques and instruments
      d.     Troubleshoot, scale up and optimize
2.      Execute, collect and review data.
3.      Implement and monitor any improvement for
efficacy.
4.      Perform and execute validation where
applicable
5.      Maintain and compile all documentations
i.e. Notebook, DCF, IQ/OQ and PV
Subordinate Objectives
1.      Identify  resolve chemical raw material
and intermediates issues.
2.      Identify  resolve performance issues.
3.      Identify  resolve processes and handling
issues.
4.      Set up and design investigations and
experiments
5.      Record, maintain and summarize all work
done in a timely manner
6.      Objective analysis of data and conclusion
to determine next course of action
7.      Write, plan and execute IQ/OQ and PV
protocols
Basic Requirements
  Experienced in working in the lab handling
chemical, reagent and basic techniques such as
column chromatography and assays
  Experienced in protein purification equipments
i.e. FPLC
  Experienced in basic analytical skills and test
methodology such as ELISA and SDS-PAGE
  Previous experience with large scale
purification preferred.
  Previous experience in optimization and
troubleshooting protein purification process
  Experience team member and collaborator
  Experience with GMP and some MFG/Operations
preferred
  Experience with Validation preferred but not
required
For more detail please see the url.

KEY REQUIREMENTS:
None Not stated
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