III - MA (1st Shift)

Genezen•Lexington, MA

11d•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. 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.

Requirements

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.
Process-oriented way of thinking and working.
Detail oriented.
Self-organized.
Able to communicate in professional way on diverse levels and channels.
Capable of taking initiative when necessary.
Flexible attitude in a challenging environment.
Intrinsically motivated.

Nice To Haves

Associate’s Degree in Life Sciences/Engineering
Bachelor’s Degree in Life Sciences/Engineering
2-4 years related industry experience
Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization.

Responsibilities

Performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.
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.
Carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.
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.
Manage equipment and support facility related projects.
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.