Sr Engineer - Drug Substance Process Engineering (JP4574)

Location: Thousand Oaks, Ca
Date Posted: 08-03-2018
Job Title:  Sr Engineer - Drug Substance Process Engineering (JP4574)
Location: Thousand Oaks, Ca.
Type: Contract
Duration: Initial 5 months with likely extension
Business Unit: Drug Substance Technology & Engineering 
 
3Key Consulting Inc. is looking for role for a Senior Engineer with experience in supporting Drug Substance Manufacturing facilities for a global, CA-based, bio-pharmaceutical company.

Job Description 
Sr. Engineer to join the Drug Substance Process Engineering team supporting Drug Substance Manufacturing facilities. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance.

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. 

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. 

Basic Qualification Requirements:
• Doctorate degree and 0-2 year of directly related experience  OR 
• Master’s degree 3+ years of directly related experience OR 
• Bachelor’s degree and 5+ years of directly related experience 

Preferred Qualifications:
• MS in Chemical/Biochemical Engineer or other biological engineering discipline and 6 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 

Onsite at Thousand Oaks Regular Hours and may require OT.

Day to Day Responsibilities:
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.
             
Employee Value Proposition: Opportunity to provide manufacturing support to cutting edge technology at Amgen.
 
Red Flags: Not enough experience.
 
Interview Process: Phone and In-person – ASAP
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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