Senior Technical Development Specialist

3 days ago

Ipswich, South Dakota, Australia beBeeFormulation Full time $150,000 - $200,000
Job Overview

The role encompasses technical oversight of product transfers, new launches, validations, and process improvement activities.

Candidates with pharmaceutical experience in drug development, process development, and manufacturing are ideal.

Responsibilities
  • Manage multiple projects and direct planning for formulation, process improvement, and troubleshooting initiatives.
  • Participate in the introduction of new products or product health projects.
  • Review annual product reviews and assist in defining corrective actions.
  • Examine site recommendations regarding Critical Process Parameters, Critical Material Attributes, and Process Control Strategies.
  • Assist the Technical Service Department in defining investigative and validation criteria.
  • Review and approve manufacturing investigations related to product quality, engineering trials, and validation protocols and reports.
  • Train local technical services and manufacturing personnel in formulation process control and design concepts.
  • Develop investigation strategies and drive project timelines as necessary.
  • Collaborate with an interdepartmental team to support local investigation and validation priorities.
  • Stay current with global regulatory guidelines, compendial requirements, and technical investigations.

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