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Technical Specifications Specialist (JP8073)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Technical Specifications Specialist (JP8073)
Location: Thousand Oaks, CA  or Cambridge, Massachusetts
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 1/15/2021
Note: Remote until COVID-19 restrictions are lifted. Must be on site M-F when the site re opens.
3 Key Consulting is hiring a Technical Specifications Specialist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Candidate will be remote until COVID restrains are lifted then MUST be on site at TO or Cambridge.
  • 2+ years of experience - anything within raw materials
  • Bachelor’s degree
  • Candidate would gain experience from: PhD research, PD, QC roles
Job Details:
  • Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
  • Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins).
  • Interface cross-functionally within Amgen (with Process Development, Quality, Supply Chain and other GMP functions).
  • Draft specifications based on raw material attributes, where they are used in the Amgen process and how they should be controlled.
  • Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks.
  • Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.
  • Skills: Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
  • Targeting candidates with 2 years’ work experience or more.

Top Must have Skill Sets:
  • Good written and verbal communication
  • Familiarity with compendia
  • Familiarity with raw materials and testing
Day-To-Day Responsibilities:
  • Manage specification creation process and revision process
  • Hold meetings with cross-functional teams
  • Own change controls to support specification activities
Employee Value Proposition:
Provides expand touchpoints to different parts, interconnect between specification and how it impacts area of organization, high level use of materials and process to support manufacturing in general.
Red Flags:
Does not have laboratory experience
Does not have familiarity with GMP
Interview Process:
Phone interview & Subsequent phone interview
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 look at 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.
3KC Talent Acquisition Team
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