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  • Burlington, MA

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Team Lead, Manufacturing - Third Shift

AMRI • Burlington, MA

Posted 5 days ago

Job Snapshot

Full-Time
Other Great Industries
Management, Manufacturing
1

Applicant

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Job Description

The Team Lead, Manufacturing will be responsible for supporting daily manufacturing activities per the weekly production calendar. Completion of assignments needed to execute a dynamic production schedule within the clean room cGMP facility at AMRI, a contract manufacturing company working in the biopharmaceutical industry. They will work with department leadership and other departments in order to complete assignments in a fast-paced and dynamic environment.


**This position will be staffed Sunday-Thursday, on our 3rd Shift**

Position Responsibilities
Other duties may be assigned

  • Support the activities of a work team, which may consist of several Manufacturing technicians. Trains and develops junior staff on aseptic technique and filling machine operation
  • Responsible for escalating any non-conforming events to the appropriate cross-functional stake holder 
  • Must be able to function independently or in a larger cross functional group.
  • Plan, oversee and participate in projects as necessary based on the department needs.
  • Can operate, troubleshoot and maintain manufacturing equipment and see through the maintenance process using work orders.
  • Conduct a daily walkthrough of the manufacturing facility to ensure status signs, logbooks and batch records are documented appropriately.
  • Willingness to perform, monitor and train aseptic processing operations and has the ability to serve as the area expert in these activities.
  • Conduct, coordinate and document quality/safety incidents and investigations, corrective and preventive actions.  
  • May establish and maintain systems to track department deliverables and trend performance against metrics.
  • Ensure the cleanroom is equipped with the necessary materials, tools and equipment necessary. 
  • Maintain manufacturing records, complies with CGMPs and internal quality system requirements
  • Works with Engineering, Materials Management, Quality Assurance and Validation to complete assignments, and ensure ongoing continuous improvement
  • Finally, a comprehensive understanding of cGMP compliance and proficiency with Windows-based Microsoft Office applications is a requirement.
  • Oversee hazardous waste handling operations in accordance with AMRI procedures

Job Requirements

Education:  associate’s degree or biotechnology certificate strongly preferred
experience in the field in lieu of certificate program may be considered

Relevant Work Experience:  3-5 years’ experience in pharmaceutical manufacturing;
Advanced degree in related field may be considered in lieu of experience

Knowledge, Skills & Abilities:


•         Previous cleanroom or cGMP experience is strongly preferred


•         Fill/finish or aseptic technique training


•         Ability to pass sterile gowning qualification required


•         Excellent communication skills


•         Desire to work collaboratively with clients, vendors, and supporting  departments


•         Must be versatile with strong prioritization skills


•        Ability to delegate tasks appropriately to a wide range of skilled technicians and function



Shift:  Third Shift
Job ID: 1001161
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