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Technical Specifications Specialist / Biopharma  (JP8050)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Technical Specifications Specialist / Biopharma  (JP8050)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 12 months with likely extensions
Business Unit: Raw Materials - Specifications
Job posting date: 1/4/2021
Note: Remote until COVID-19 restrictions are lifted.
 
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:
  • 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, Primary Containers). Interface cross-functionally within the client (with Process Development, Quality, Supply Chain and other GMP functions) and externally with the client raw material suppliers.
  • 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 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); preference will be given to advance degree holders and/or those who have industry and project management experience. Targeting PHD/Master level candidates with 6 months’ work experience or more.
 
Top Must have Skill Sets:
  • Knowledge of analytical methods (depends on education)
  • Data Analytics experience
  • Troubleshooting experience
  • Team player
  • Problem solver
 
Day-To-Day Responsibilities:
  • Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
  • 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.
     
Employee Value Proposition:
Huge cross collaboration for this project, working at a biotech/pharma company, technical documentation experience growth, project exposure to multiple departments
 
Interview Process:
phone/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 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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