Senior Engineer – Biotech Drug Substance Tech Transfer (JP5101)

Location: Cambridge, MA
Date Posted: 12-07-2018
Job Title:  Senior Engineer – Biotech Drug Substance Tech Transfer (JP5101)
Job Site:  Cambridge MA
Type: Contract
Duration: 24 months with likely extension
Business Unit: AMA and External PE
 
3Key Consulting Inc. is looking for a an Engineer for a global bio-pharmaceutical company, with experience in Drug Substance Manufacturing.
 
Description:
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%

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)
  • 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
 
Top Must Have Skill Sets:
  • Technology Transfer - Particularly experience transferring processes from development scale to implementation at manufacturing plant(s)
  • Synthetic Process Development
  • Optimization, development, or processing of synthetic unit operations: Organic Chemical reactions, separations, distillation, crystallization, drying, milling, etc.
  • Regulatory documentation - drafting or supporting regulated documents for INDs and NDAs
             
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.
 
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 take a 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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