Manufacturing Supervisor - 2nd Shift (2:00-10:30pm)

JOB SUMMARY

With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into Manufacturing.

This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 2:00-10:30pm. The Supervisor will report to the Director of Manufacturing and Compliance.

ESSENTIAL JOB FUNCTIONS

• Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
• Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
• Primary contact for troubleshooting and issue resolution or escalation
• Create and follow up on work orders
• Communicate/ coordinate day’s scheduling and staffing plan
• Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities
• Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
• Responsible for floor inventory and communicating schedule changes as needed
• Identify and support process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, take action on safety issues and risks
• Ensure that the department is in a continuous state of readiness for production and GMP audits.
• When needed, independently perform manufacturing of client's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
• As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.

JOB QUALIFICATIONS

• Prior leadership experience in GMP manufacturing facility
• Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
• Experience completing moderate to complex schedules
• Hands -on experience in writing and reviewing the documentation
• Experience in (bio)-manufacturing unit operations
• Good writing and oral communication skills
• The work schedule may require adjustments to support production activities

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

Work Environment:

• Regularly sit for long periods of time

Movement:

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail