About this role

  • Posted on

  • Location

    Boston, Massachusetts

  • Salary

    $125000.00 - $140000.00 per annum

  • Type

    Permanent

  • Division

    Pharmaceutical Manufacturing Jobs

  • Reference

    BBBH15385UK_1623848551

  • Start date

    ASAP

  • Managing this role

Consultant

Urszula Kaldi

+44 (0) 203 8543 089

urszula.kaldi@xplorepharma.com

154-158 Shoreditch High Street

Description

Responsibilities

  • Provide technical oversight and strategic input for pilot plant and manufacturing activities
  • Lead technology transfer from process development to manufacturing w
  • Preparation of CMC content for technology transfer, and manufacturing support
  • Organize daily operations for a team of engineers, scientists and technical SMEs
  • Establish and maintain an understanding of current trends in manufacture, scale-up of technologies, and best practices in technology transfer
  • Understand statistical methods of process validation, process trending, and experimental design using design of experiments (DoE)
  • Support scale-up of new innovative and global regulatory processes
  • Development of product and processes to meet our global strategy
  • Provide manufacturing technical support, including process troubleshooting, root cause analysis, and investigation on process and/or quality discrepancies and deviations during GMP production
  • Work with cross functional teams including Research, Regulatory and Clinical to establish manufacturing plans and deliver on the established Production Operation’s annual goals and objectives
  • Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation
  • Manage daily production operations in early development builds, early and late phase clinical trials, and commercial manufacturing as needed
  • Establish and revise Batch Records, Standard Operating Procedures and other operational documents as needed, review Qualification/Validation protocols and reports, and other essential cGMP documents
  • Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion, and with Supply Chain to manage raw materials and deliver product per the timelines

Qualifications

  • Bachelor’s Degree in Scientific, Engineering or related discipline
  • 3 – 5 years of experience in pharmaceutical drug product manufacturing with specific responsibilities in supervision and manufacturing of product for clinical trials or equivalent experience
  • In-depth knowledge of cGLPs and cGMPs
  • Experience writing and developing SOPs and other regulatory documentation
  • Build effective manufacturing team
  • Must be able to work in a cleanroom environment.

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