AMRI Manufacturing Supervisor in Burlington, Massachusetts
The Manufacturing Supervisor will be responsible for the planning of 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. The supervisor will work with Engineering, Materials Management, Quality Assurance and Validation to complete assignments in a fast-paced and dynamic environment.
Position Responsibilities Other duties may be assigned
· Coordinate 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 working with management on team performance management, including annual reviews, disciplinary actions, training status, employee development plans, and succession planning
· 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 and train aseptic processing operations and has the ability to serve as the lead operator in these activities.
· Ensures direct reports maintain 100% up to date on their training curricula.
· 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. Will order supplies and issues work orders as needed
· 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
· Ability to become fluent in all functional areas, and provide leadership, in the absence of the department/shift manager
· Finally, a comprehensive understanding of cGMP compliance and proficiency with Windows-based Microsoft Office applications is a requirement.
· Performs hazardous waste handling operations in accordance with AMRI procedures
· Performs waste container filling operations and applying identification markers and labels
· Movement of waste from generation point to central accumulation area
Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education: associate’s degree or biotechnology certificate strongly preferred experience in the field in lieu of certificate program may be considered
Relevant Work Experience: 5-7 years’ experience in pharmaceutical manufacturing; Advanced degree in related field may be considered in lieu of experience
Knowledge, Skills & Abilities:
· Former supervision skills strongly preferred
· Previous cleanroom or cGMP experience is highly desirable
· Fill/finish or aseptic technique training strongly preferred
· 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
All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.
Organization: *AMRI Burlington
Title: Manufacturing Supervisor
Requisition ID: 1002105
EOE Protected Veterans/Disability