Production Manager

Job Locations US-MA-Bedford
Posted Date 3 months ago(12/18/2020 5:02 PM)
Job ID
# of Openings


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. 


  • 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.
  • Supervise Manufacturing Production Operations personnel




  • Bachelor’s Degree in Scientific, Engineering or related discipline
  • 3 years of experience in 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 think critically, effectively make decisions and problem-solve as needed
  • Ability to effectively plan and execute to manufacturing schedule
  • Excellent communication skills at all levels
  • Ability to develop and maintain department and cross-functional relationships
  • Build effective manufacturing team
  • Mobility and ability to lift up to 50 lbs.
  • Must be able to work in a cleanroom environment.


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