Scientist (JP4953)

Location: West Greenwich, RI
Date Posted: 11-01-2018
Job Title:  Scientist (JP4953)
Location: West Greenwich, RI.
Employment Type:  Contract
Business Unit:  Commercial Attribute Sciences
Duration: 9+ months (likely extensions)
 
3Key Consulting Inc. is recruiting for a Process Development Scientist to work in a non-laboratory based role focused on method transfer with experience in methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
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.
 
Top Must-Have Skill Sets:
  • 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.
  • 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.
  • Two roles will focus on assisting larger team of Method transfer and validation group.
  •  
Day to Day Responsibilities
Will work through task list daily on checkups with status, reporting out deliverables, writing protocols (heavy portion of job), coordinating deliverables from many team members
 
Basic Qualifications:
  • PhD., OR
  • Master’s degree and 4 years of Operations or Scientific experience, OR
  • Bachelor’s degree and 6 years of Operations or Scientific experience
  • 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
 
Preferred Qualifications:
  • 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
 
Why This Position Is Open:
This will augment current FTE roles to support extra protocols and workload. This is a new group at Amgen.
 
Employee Value Proposition:
This is a new group within Amgen that works with the entire global portfolio. This person would get to see variations of work implemented on a global scale. This would provide an immense learning opportunity, these skill sets are very transferable to other roles
 
Red Flags:
  • Not able to communicate clearly.
  • Not task driven.
  • Not detail oriented.
 
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
 
 
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