III (2nd Shift)

Genezen•Lexington, MA

13d•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 Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation. With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. This position is located in Lexington, MA and reports to the MFG Supervisor.

Requirements

Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures
Hands-on experience in writing and reviewing documentation
Experience in (bio)-manufacturing unit operations (USP and/or DSP)
Good writing and oral communication skills
Applies experience and skills to complete assigned work within own area of expertise
Works within standard operating procedures and/or scientific methods
Comfortably able to lift up to 40lbs
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned
Has process-oriented way of thinking and working
Is detail oriented
Is self-organized
Is able to communicate in professional way on diverse levels and channels
Is capable of taking initiative when necessary
Has a flexible attitude in a challenging environment
Is intrinsically motivated

Nice To Haves

Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization

Responsibilities

Attend daily meetings including shift hand off and ensure relevant information is shared between shifts.
Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state
Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
Demonstrating general knowledge of aseptic techniques
Perform troubleshooting activities according to SOPs
Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed.
Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms
Perform page reviews in BPRs, SLRs, Logbooks, and Forms
Carry out work in a safe manner, notifying management of safety issues and risks
Maintain up-to-date training folder for applicable processes
Required to work holidays and overtime as needed to support the manufacturing process
Perform scheduled cleaning of equipment
Perform standardization of equipment
Support product change over activities
Support equipment and process qualifications if needed
Escalate work requests to Senior or Lead Technicians for submission in work request management system
Propose continuous improvement, process, and human performance document revisions
Escalate and contributes to process improvement and manufacturing Continuous Improvement items.
Develop and maintain personal development plan
Provide annual performance self-assessment