Description
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Title: Sr Engineer - MA
location: Cambridge, 02141
Contract - 26 months (Possible of extension)
Labor Type Food Service
Comments:
- Location: Cambridge, MA or Thousand Oaks, CA
- Domestic and International Travel: up to 20%
JOB SUMMARY
- 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, modelling, 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 modelling 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 is the Position Open?
Supplement additional workload on team
Top 3 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
Day to Day Responsibilities:
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, modelling, optimization, characterization, regulatory support and commercial production of synthetic organic molecules.
Possible Extension:
Yes
Interview Process:
Initial phone screen. If ideal, then onsite