Manager, Production

Job Locations US-MA-Bedford
Posted Date 2 weeks ago(2/8/2018 10:34 AM)
Job ID
2018-1052
# of Openings
1
Category
Operations

Overview

Responsible for supervising clinical and commercial manufacturing operations. Ensure production operations are conducted in accordance with regulatory and cGMP compliance, while delivering to the production plan of record.  Instill a culture of continuous improvement within production operations, and foster team growth environment. Collaborate with Regulatory/Quality, Facilities, and Development with regards to project plans and the successful production execution of late phase clinical, new product launch and sustainable commercial manufacturing activities. 

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.
  • Perform other duties as required.

Qualifications

  • Bachelor’s Degree in Scientific, Engineering or related discipline
  • 10 years of experience in pharmaceutical drug product manufacturing with specific responsibilities in supervision and new product introduction
  • 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
  • Mobility and ability to lift up to 50 lbs.

  • Must be able to work in a cleanroom environment.

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