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- Burlington, MA
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Team Lead, Manufacturing - Third Shift
AMRI • Burlington, MA
Posted 11 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
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