Senior Chemical Engineer - BioPharma (JP4832)​

Location: Thousand Oaks, ca
Date Posted: 10-10-2018
Job Title: Senior Chemical Engineer - BioPharma (JP4832)
Location: Thousand Oaks, CA. or Cambridge, MA.
Employment Type: Contract
Business Unit:  Scientific Process Development
Duration:  30+ months (likely extensions)
 
3Key Consulting Inc. is recruiting for a Senior Engineer with  5+ years’ experience (depends on education) in chemical engineering, drug substance development, technical transfer of processes, and scale-up for a global, CA-based, bio-pharmaceutical company.  Fluency in German and/or Italian is a plus!
 
Job Description:
Contractor will be a team member of Amgen’s “strive for five” initiative and will be able to work at Amgen’s Thousand Oaks, CA. or Cambridge, MA. campuses.   For this role in the Drug Substance Technologies and Engineering Team, you will have responsibilities focused on the technical transfer and engineering support of synthetics processes to produce Amgen’s drug substance(s) at Contract Manufacturing Organizations (CMOs) across all phases of development and commercialization.  The qualified candidate will be well versed in chemical engineering fundamentals, process development, regulatory requirements and scale up with the ability to apply their skills to drive understanding and implementation of processes that deliver Amgen’s pipeline. You will work with a cross functional group of engineers and scientists through the process development cycle at Amgen and the contract site(s) to ensure successful technology transfer and manufacturing. The Sr. Engineer will also use their experience in support of process execution, equipment utilization, optimization, scheduling and documentation. The ideal candidate will have expertise in tech transfer, process development, modeling, optimization, characterization, regulatory support and commercial production of synthetic organic molecules.
 
Domestic and International Travel: up to 20%
 
Top Must-Have Skill Sets:
  • Well versed in chemical engineering fundamentals.
  • Process development.
  • Regulatory requirements and scale up.
 
Day to Day Responsibilities
You will work with a cross functional group of engineers and scientists through the process development cycle at Amgen and the contract site(s) to ensure successful technology transfer and manufacturing. The Sr. Engineer will also use their experience in support of process execution, equipment utilization, optimization, scheduling and documentation. The ideal candidate will have expertise in tech transfer, process development, modeling, optimization, characterization, regulatory support and commercial production of synthetic organic molecules.
 
Basic Qualifications:
Doctorate Degree
OR
Master’s degree and 3 years of Engineering or Operations experience
OR
Bachelor’s degree and 5 years of Engineering or Operations experience
OR
Associate’s degree and 10 years of Engineering or Operations experience
OR
High School Diploma/GED and 12 years of Engineering or Operations experience
 
Preferred Qualifications:
  • Engineer with 5+ years of experience in providing and driving engineering deliverables for pharmaceutical processes and product development.
  • Experience related to process development, technology transfer, scale-up and manufacturing of synthetic molecules in regulated environment. This includes technical support for nonconformance investigations and other commercial support activities.
  • Ability to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.
  • Possess strong understanding of regulatory and cGMP requirements.
  • Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of analytical techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, particle size determination, etc.
  • Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements.
  • Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.
  • Experience in working closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide enhanced understanding and guidance for synthesis and unit operations.
  • Contribute to key regulatory and quality activities such as non-conformances, process performance qualification and continued process verification.
  • Experience with Quality by Design and Process Analytical Technologies, applied to pharmaceutical development.
  • Strong communication and presentation skills, excellence in team work, mature process fit proficiency, command of operations plant safety practices.
  • Fluency in German and/or Italian is a plus.
 
Why This Position Is Open:
Strive for 5 Project - Need additional support for the new project Oncology portfolio.
 
Employee Value Proposition:
High visibility project. Chance to work with world class scientific process development staff.
 
Red Flags:
Not enough experience on qualifications needed for this role.
 
Interview process:
Phone followed by 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 particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
or
this job portal is powered by CATS