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Pharmaceutical Manufacturing Specialist

2 months ago


Berkeley, California, United States Insight Global Full time
Job Summary

We are seeking a highly skilled Pharmaceutical Manufacturing Technician to join our team at Insight Global. As a key member of our manufacturing team, you will be responsible for the clinical manufacturing of monoclonal antibodies (mAB) drug substance within our Cell Culture Technology Center (CCTC).

Key Responsibilities
  • Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation, and Weigh/Dispense, including freezing and put away products.
  • Collaborate closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.
  • Ensure all activities are performed to schedule and manufacture products in various phases of product life cycles from clinical through launch.
  • Clearly understand, communicate, and manage differences in terms of documentation, sample handling, automation, and cGMPs for different phases of product life cycle.
  • Provide feedback and troubleshoot single-use technology (SUT) from end to end in the manufacturing process.
  • Work cross-functionally to ensure process control and issue escalation and investigation.
  • Redline and review controlled documents for various equipment and processes.
  • Effectively employ all methods of communication to ensure knowledge and information transfer across shifts, to management, and cross-functionally.
  • Raise and support investigation of deviations.
  • Participate in safety investigations for CCTC and promote safe behaviors at all times.
Requirements
  • Minimum of BS in a science-related field (transferable skills will be considered) or an equivalent combination of education and experience.
  • Minimum of 1+ years' experience.
  • Experience in cGMP and GDP requirements for pharmaceutical manufacturing.
  • Experience with business IT systems (Delta V, Team, Outlook, SAP, etc.).
Benefits

Insight Global offers a competitive compensation package, including medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401(k) retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.