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

Genezen•Lexington, MA

20h•Onsite

About The Position

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. 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.

Requirements

Prior leadership experience in GMP manufacturing facility
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
Adaptability required as work schedule may change based on business needs
Criminal background check required
Process-oriented way of thinking and working
Detail-Oriented
Self-organized
Able to communicate professionally on diverse levels and channels
Capable of taking the initiative when necessary
Flexible attitude in a challenging environment
Intrinsically motivated

Nice To Haves

Bachelor’s Degree in Life Sciences/Engineering
3-5+ years of cGMP experience
Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization

Responsibilities

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 uniQure’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.