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Technical Specialist Raw Materials, Biopharma - Remote (JP9770)

Cambridge, MA · Biotech/Pharmaceutical
Job Title: Technical Specialist Raw Materials, Biopharma - Remote (JP9770)
Location: Cambridge, MA (Remote Work)
Employment Type: Contract

Business Unit: Raw Materials - Specifications 
Duration: 12 months with likely extensions
Job posting date: 2/9/2022

3 Key Consulting is hiring a Technical Specialist Raw Materials-Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • Candidate Must have Experience with pharmacopoeias “USP, EP (Ph. Eur), JP, ChP
  • Manage the development and implementation of clinical and commercial raw material specifications, material master data, and other specification related documents.
  • Have an understanding and knowledge of the raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins).
    Understand and develop the strategy for functionally equivalent materials for inclusion on production BOMs and material master data setup
  • Interface cross-functionally within the (with Process Development, Quality, Supply Chain and other GMP functions)
  • Other responsibilities include Quality System record ownership including change control, master data change control, deviation, and CAPA.
  • Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).

Own Material Specification activities:
  • Draft specifications based on raw material attributes, where they are used in the client process and how they should be controlled
  • Facilitate specification development meetings
  • Generate meeting minutes/action items to partners to ensure completion of tasks
  • Own Master Data onboarding activities
  • Create and own Master Data Changes in Trackwise
  • Determine master data strategy for inclusion on BOMs
  • Ensure Animal Derived Material tissue and origin correctly identified in SAP
  • Manage material creation workflows by ensuring SAP data agents complete all tasks on time to meet onboarding need-by date
  • Coordinate with site warehouse, purchasing and accounting teams
  • Ensure material status is updated for use at manufacturing sites
     
Top Must have Skill Sets:
  • Knowledge of Raw Materials
  • Work in a fast paced environment
  • Quality control background
  • Degree in science background (biology & chemistry); PHD with little to no experience will qualified

Day-To-Day Responsibilities:
  • Author Raw Material Specifications
  • Lead cross-functional specification development meetings
  • Manage master data change control
     
Red Flags:
  • No experience with raw materials
  • No experience authoring documents
  • No experience with Quality Systems
  • No experience in pharmacopoeias “USP, EP (Ph. Eur), JP, ChP.
     
Interview Process:
Phone and Video phone

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.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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