About this role

  • Posted on

  • Location

    Boston, Massachusetts

  • Salary

    $100000.00 - $120000.00 per annum

  • Type

    Permanent

  • Division

    Pharmaceutical Manufacturing Jobs

  • Reference

    BBBH19888UK_1626206945

  • 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

  • Establish 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.
  • Instill a culture of continuous process improvement with a quality focus. Pursue industry “best practices” associated with clinical and commercial production operations.
  • Manage daily production operations in late phase clinical, new product launch and commercial manufacturing.
  • Review Master Batch Records, SOPs, Qualification/Validation protocols and reports, and other essential cGMP documents.
  • Write and revise Standard Operating Procedures and other operational documents as needed.
  • Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion.
  • Provide appropriate coaching, development, and associated performance management for the production operations staff.

Qualifications

  • Bachelor’s Degree in Scientific, Engineering or related discipline
  • 3 years of experience in medical device or pharmaceutical drug product manufacturing with specific responsibilities in supervision and new product introduction or equivalent experience
  • In-depth knowledge of cGMPs and working in a regulated environment
  • Experience writing and developing SOPs and other regulatory documentation
  • Proficiency in Microsoft Office Applications
  • Excellent organization, communication and analytical skills are required
  • Ability to develop and maintain department and cross-functional relationships and build effective manufacturing team
  • Experience working in cleanroom environment

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