Sr. Scientist / Los Angeles, CA / $105k

Hayward  ‐ Onsite
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Description

Job Description

Responsible for providing technical oversight of biologics drug product manufacturing processes at CMOs (fill/finish). This position works closely with internal functions (Contract Manufacturing, Technical Development, Regulatory and Quality) and external service providers to ensure post drug substance processes perform as expected. Responsibilities include:
  • Technology transfer of biologics drug product manufacturing processes (fill/finish) to contract manufacturing organizations (CMOs)
  • Oversight of process validation activities associated with new and modified drug product processes
  • Lead formal investigations to address manufacturing deviations or product complaints
  • Provide routine commercial drug product support including exceptions resolution, change control, technical troubleshooting, etc.
  • Provide technical support for drug product equipment and process changes being made at CMOs including review of change control/CAPA documentation
  • Establish systems for tracking performance of drug product processes and report KPIs to management on a periodic basis
  • Identify, assess and implement new technologies/process improvements for drug product processes in partnership with internal and external parties
  • Author internal reports documenting technology transfer, validation, investigation, process improvement activities


Qualifications - Life Sciences or Engineering degree with experience.
  • Subject Matter Expert in a core technical discipline.
  • Degree with experience.
    Technical expert in a core discipline.
  • Knowledgeable on core manufacturing operations (past experience supporting fill/finish manufacturing processes preferred)
  • Excellent technical writing and presentation skills.
  • Knowledgeable on Regulatory and Quality requirements
  • Education B.S. plus 12 years of experience
  • MS. plus 10 years of experience
  • Ph.D. plus 6 years of experience


Please respond with your contact info and a word document format of your resume to b.ross(@)realstaffing.com to apply for an interview! Thank you for your time and interest!

To find out more about Real please visit www.realstaffing.com
Start date
08/2013
From
Real Staffing
Published at
29.10.2013
Project ID:
619506
Contract type
Permanent
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