Process Engineer – Drug Substance Technology Transfer (JP4493)

Location: Cambridge, MA
Date Posted: 07-12-2018
Job Title:  Process Engineer – Drug Substance Technology Transfer (JP4493)
Job Site:  Cambridge MA
Type: Contract
Duration: 18 months with likely extension
Business Unit: AMA and External PE
 
3Key Consulting Inc. is looking for a Process Engineer for a global bio-pharmaceutical company.
 
Description:
Process Engineer – Upstream/Downstream

The ideal candidate for this role will have had 2-3 years of experience support drug substance manufacturing operations through technical investigations and executing technology transfers / new product introductions in to a GMP Facility. The candidate will have breadth of to provide on the floor technically support of upstream and downstream unit operations (operation of stainless steel and sing use bioreactors, dead end filtration, tangential flow filtration, column chromatography, ect.). The candidate should have a depth of knowledge in one of these areas.

The successful candidate will apply fundamental scientific principles to Biopharmaceutical manufacturing processes (upstream cell culture and downstream purification) including:
·       A good understanding of cell culture processes; scale up factors from bench to commercial, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes. Harvest and clarification processes used for mammalian cell culture processes.
·       A good understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations.
·       Familiarity with chemical engineering principles for the scale up of unit operations from bench scale to commercial scale. Analyzing manufacturability; understanding process capabilities and means to achieve yield optimizations and increased efficiencies.


The candidate will execute on technology transfer projects, resolve processing issues, and conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials. The candidate will be responsible for providing on the floor support during clinical and validation runs and compiling relevant process data. The candidate will provide technical support and assist in the troubleshooting of clinical and commercial drug substance manufacturing.

Basic Qualifications (Engineer)
- Doctorate degree  OR
- Master’s degree 3+ years of directly related experience  OR
- Bachelor’s degree and 5+ years of directly related experience OR
- Associate's degree and 10 years of Process Development experience OR
- High school diploma/GED & 12 years of Process Development experience

Preferred Qualifications (Engineer)
·       1-2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
·       Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
·       Excellent written and verbal communication
·       Demonstrated ability to work under moderate direction.
·       Able to analyze and interpret data
·       Be a self-starter with the ability to take on several projects at one time
 
Top 3 Must Have Skill Sets:
1. Drug substance Technology Transfer
2. Expertise in Upstream or downstream scale up bench scale to commercial scale
3. Ability to lead technical investigation in GMP space
 
Day to Day Responsibilities:
The candidate will execute on technology transfer projects, resolve processing issues, and conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials. The Candidate will be evaluated on their ability to conduct and document technical assessments with sound scientific judgement according to schedule.
 
Employee Value Proposition:
A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen remains committed to advancing science to dramatically improve people’s lives.
 
Interview Process:
Phone screen followed by a 1-day interview processes with 4-8 people. Interviews can start immediately.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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