Scientist – Biotech Process Development (JP5096)
West Greenwich, Rhode Island
12 months with likely extension
3Key Consulting Inc. is recruiting for a Scientist with bioscience credentials and back ground in biotech process development and manufacturing, for a global CA-based bio-pharmaceutical company
Amgen is a biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Amgen's Attribute Sciences group within Process Development is seeking a Scientist. The Process Development Scientist will be responsible for the strategy, execution, analysis and communication of method transfer and method validation protocol and report writing. This candidate will help to drive improving this process and effectively communicate results with internal and external partners across a global network.
The Scientist role in Commercial Process Development will be part of a team responsible for authoring method transfer and method validation protocols and reports for clinical/commercial programs for the following method platforms: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocols and reports will be authored according to regulatory and industry guidelines (i.e., ICH). This individual will support clinical and commercial locations throughout the company. This position works closely with representatives from key functions within Process Development, Manufacturing and Quality.
• OR Master’s degree and 4 years of Operations or Scientific experience
• OR Bachelor’s degree and 6 years of Operations or Scientific experience
• PhD in Biochemistry, Analytical Chemistry, Physical or Life Sciences
• Strong understanding and hands-on experience of methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General
• Strong understanding and hands-on experience with method transfer and method validation processes with direct experience from a Pharmaceutical or Biotechnology Company.
• Advanced knowledge of analytical methods/technologies used in biologic and synthetic development and manufacturing
• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
• Demonstrated ability to critically analyze and interrogate various analytical data sets to drive and influence the process
• Demonstrated ability to propose and drive new scientific initiatives
Top Must have Skill Sets
Employee Value Proposition
- Will be heavily electronically dependent.
- Not a laboratory-based role. Role will be the production of protocols, reports, documentation coordination, task tracking, document routing Two roles will focus on assisting larger team of Method transfer and validation group.
- Skills required EDMQ Lims, LMES, Empower.
- Communication electronically Ability to follow understand documentation requirements/SOPS Knowledge of analytical methods and techniques used (not all, but some background) QC background desirable
This is a great opportunity to see how Amgen is leading the industry in supply chain processes using digital flow, data and new technologies.
Experience is not relevant to the job description
Phone and/or in-person interviews will be accommodated.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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.