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- Burlington, MA
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Team Lead, Manufacturing - Third Shift
AMRI • Burlington, MA
Posted 5 days ago
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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**
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
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
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