Process Development Specialist

6 days ago


Lansdale, Pennsylvania, United States Genovice Full time
Job Overview

Genovice is seeking a highly skilled Process Engineer to support the execution of sterile drug product technical transfers. The successful candidate will be responsible for authoring technical documentation and supporting technical development studies through protocol development, floor execution, sample submission, data analysis, and reporting.

Key Responsibilities
  • Design process development studies based on direction from Drug Product Tech Transfer Lead
  • Author and review study protocols (based on templates or examples, where available)
  • Support planning & execution of full-scale process development, engineering, or qualification batches
  • Lead data collection, analysis, and report writing
  • Second-person review of technical documents
  • Change control support for technical transfers
  • Change control support and/or data analysis support for commercial drug product production based on business needs
Requirements
  • Solid technical writing skills (protocols, reports)
  • Able to execute a study protocol following cGMPs
  • Able to perform data analysis (statistical analysis using JMP)
  • Able to work independently and deliver results, under oversight of Tech Transfer Lead
  • Able to adapt to changes in work priorities (e.g. shift between projects)
Preferred Qualifications
  • Experience in sterile drug product technical transfers
  • Experience with commercial manufacturing of sterile drug product
  • Experience with sterile manufacturing processes (environmental controls, aseptic techniques)
What We Offer

Genovice offers a competitive hourly rate of $110 and a contract duration of 12-18 months. The role requires up to 25% travel, with all travel expenses paid.



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