Technical Specifications Specialist

Advanced Bio-Logic Solutions Corp Thousand Oaks , CA 91360

Posted 2 months ago

Top 3 Must Have Skill Sets: hard skills
  • knowledge of analytical methods (depends on education)
  • Data Analytics experience
  • Troubleshooting experience
soft skills
  • 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.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, Primary Containers). Interface cross-functionally within Amgen (with Process Development, Quality, Supply Chain and other GMP functions) and externally with Amgen raw material suppliers. 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); 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."This posting is for Contingent Worker, not an FTE"
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Technical Specifications Specialist

Advanced Bio-Logic Solutions Corp