Manufacturing Technician I - Buffer Prep (M-F, 7am-3:30pm)

Genezen•Lexington, KY

6d•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. Genezen is seeking a Manufacturing Technician I to play a hands-on-role in the production of clinical and/or commercial cell and gene therapy products, helping our partners deliver life-changing advanced therapies to patients. This role is responsible for performing routine and non-routine manufacturing operations in a cGMP environment, including process execution, in-process controls, equipment operation, and documentation, while working closely with MSAT, QC, QA, Engineering, and Validation teams to ensure safe, compliant, and high-quality manufacturing operations. The position is Monday-Friday, 7am-3:30pm in our Lexington, MA facility.

Requirements

0-2 years prior manufacturing experience, preferably experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization.
Hands-on experience in writing and reviewing documentation
Experience in (bio)-manufacturing unit operations (USP and/or DSP)
Excellent written, verbal, and interpersonal communication skills with ability to effectively communicate across departments.
Ability to effectively apply technical expertise and experience to achieve assigned objectives.
Working knowledge of and adherence to SOPs, Good Documentation Practices (GDP), and applicable regulatory requirements.
Commitment to maintaining compliance with company internal and regulatory (EMA, FDA) policies, processes and procedures.
Exceptional attention to detail, strong organizational skills, and a structured, process-driven approach to work.
Ability to prioritize tasks and manage multiple responsibilities effectively.
Proactive, self-motivated, and capable of exercising sound judgment and initiative.
Flexible and adaptable in a rapidly changing manufacturing and development environment.
Adaptability required as work schedule may change based on business needs
Ability to lift up to 40 lbs
Criminal background check required

Nice To Haves

High School, Associates, or Bachelor's Degree, preferably in Life Sciences/Engineering field.

Responsibilities

Execute routine and non-routine production activities according to the manufacturing schedule.
Follow cGMP requirements, SOPs, batch records, and solution preparation records.
Use the Enterprise Resource Planning (ERP) system to execute transactions accurately and in real-time.
Demonstrate and apply aseptic processing techniques.
Operate in production areas such as, but not limited to, Pre-culture, USP, DSP, buffer preparation, and Fill Finish.
Perform troubleshooting activities within established procedures.
Participate in shift handoffs and communicate critical production information.
Support off-shift, overtime, and holiday production activities as required.
Complete manufacturing documentation accurately and in real time following GDP principles.
Review batch records, solution records, logbooks, and forms for completeness and accuracy.
Maintain training compliance and ensure required qualifications remain current.
Support a safe working environment by identifying and escalating potential safety concerns.
Perform routine equipment cleaning and standardization activities.
Support product changeovers and manufacturing readiness activities.
Assist with equipment, process qualification, and validation efforts.
Conduct facility walkthroughs and maintain manufacturing areas in an inspection-ready state.
Coordinate equipment and facility issues with Senior and Lead Technicians.
Maintain an individual development plan and continuously build technical expertise.
Complete annual self-assessments and actively participate in performance development discussions.
Demonstrate open-mindedness and self-awareness in receiving and acting upon feedback.