Director Drug Product (Biologic) - Apex Systems : Job Details

Director Drug Product (Biologic)

Apex Systems

Job Location : all cities,MA, USA

Posted on : 2024-11-17T06:06:01Z

Job Description :

Director Drug Product (Biologic) 2049028Location: Greater Boston, MA (Hybrid)

Job Overview: This Biologics focused CMC leader will oversee formulation development, drug product manufacturing processes, and coordinate tech transfers with CDMOs.

Primary Job Responsibilities:

  • Drive strategic and technical initiatives for drug product development including optimization and scale up.
  • Manage CDMO activities to ensure drug product manufacturing processes are developed and maintained.
  • Design and execute Drug Product development studies (pre-formulation, formulation, and short-term stability).
  • Develop liquid and lyophilized formulations to support clinical stage biologic therapies.

    • Primary Job Requirements:

  • Advanced degree in a scientific field preferred with over 7 years of biologic drug product development experience.
  • Expertise in developing lyophilized and liquid biologic formulations.
  • Strong exposure to managing CDMO's and tech transfer related activities.
  • Knowledgeable in ICH guidelines, GMPs, and regulatory standards with excellent teamwork and communication abilities.
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