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Scientist – Biotech (JP7245)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Scientist – Biotech (JP7245)
Location: Thousand Oaks, CA
Employment Type:  Contract
Business Unit:  Method Stewardship
Duration: 12+ months (with likely extensions)
 
3 Key Consulting is hiring a Scientist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Ideal candidate:
  • Master in Biochemistry, Analytical Chemistry, Physical or Life Sciences.
  • Strong understanding of method validation/transfer for methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)

Job Description:
Biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Attribute Sciences group within Process Development is seeking a Scientist. The scientist will be responsible for the data verification, drafting, reviewing, and compilation for method transfer and method validation protocols and reports. The position will be a documentation centric role and the candidate will need to have experience with document management systems.

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 late stage 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.

Basic Qualifications:
  • Master’s degree and 3 years of Operations or Scientific experience
  • OR Bachelor’s degree and 5 years of Operations or Scientific experience
  • OR Associate’s degree and 10 years of Operations or Scientific experience
  • OR High school diploma / GED and 12 years of Operations or Scientific experience
     
Preferred Qualifications:
  • Master in Biochemistry, Analytical Chemistry, Physical or Life Sciences
  • Strong understanding of method validation/transfer for methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)
  • Direct experience with method transfer and method validation processes from a Pharmaceutical or Biotechnology Company.
  • 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:
  • Organization of heavy workload, communication skills (verbal, written).
  • Ability to conduct detail-oriented work - data verification, protocol writing, reporting drafting, data review
  • Tracking Project Management skills (MS Project Preferred).
  • Scientific writing skills, reviewing and writing technical documentation
 
Day to Day Responsibilities:
Data verification of documents, drafting documents from templates (protocols/reports), organizing data for other team members to view, documentation heavy workload supporting Amgen members.

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:
Lack of detail orientation, not able to quickly verbalize tasks, lack of any experience in quality/biopharma organizations.
 
Interview process:
Phone screening followed Skype
 
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/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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