Process Engineer - Drug Substance (JP4877)

Location: Thousand Oaks, CA
Date Posted: 10-25-2018
Job Title:  Process Engineer – Drug Substance (JP4877)
Location: Thousand Oaks, CA
Employment Type: Contract to Hire
Duration: 6+ months
Business Unit: Drug Substance Technology & Engineering
 
3Key Consulting Inc. is looking for a Process Engineer with 3 + years of production support experience (experience with at scale processes) and biologic manufacturing experience for a global bio-pharmaceutical company.
 
Job Description: 
 
  • The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing. 
  • This individual will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production. 
  • Scope includes: transfer processes and process improvements from the laboratory into the manufacturing facility and between manufacturing sites; provide on-the-floor technical support for successful scale-up, transfer of process technology, and for routine clinical and/or commercial production; lead data trending and advanced statistical process analysis
  • Provide technical support for all process related deviations (NCs), CAPAs and change controls; 
  • Provide technical support for new equipment, technology and capital projects in the facility; identify and support process related operational excellence opportunities;
  • Manage Process Validation activities occurring at the site; presentation of process performance at team and management meetings
  • Process modeling to guide process development activities, identify process implementation issues and drive optimization
  • Technical project management; support of regulatory filings and inspections.  
 
Basic Qualifications:
Doctorate degree and 0-2 year of directly related experience 
OR 
Master’s degree 6+ years of directly related experience 
OR 
Bachelor’s degree and 8+ years of directly related experience 

Preferred Qualifications:  
 
  • MS in Chemical/Biochemical Engineer or other biological engineering discipline and 8 years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP) 
  • Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance. 
  • In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations 
    AND/OR 
  • In-depth understanding of cell culture process scale up, mass oxygen transfer, metabolism profiling, process deviation impact to growth and quality attributes, harvest/clarification processes, raw material including media component impact to cell culture. 
  • Good knowledge of aseptic processing/techniques. 
  • Process validation, process characterization and process monitoring experience 
  • Experience in supporting regulatory inspections 
  • Process development experience in supporting cGMP manufacturing at large scale 
  • Good written and verbal communication skills 
  • Experience in preparing regulatory filings and participation in regulatory inspections 
  • Process development and optimization experience with late stage or commercial products 
  • Process equipment design and evaluation expertise 
  • Experience with risk analysis methodologies 
  • Independently motivated with ability to multi-task and work in teams 
  • Excellent organizational, leadership, teamwork, and communication skills are required as well as the ability to work effectively in a dynamic and challenging environment with enthusiasm and a proactive positive attitude. 


Employee Value Proposition:
Opportunity to provide manufacturing support to cutting edge technology at Amgen.

Interview Process:
Phone interview first and then In-person interview. 

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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