Manufacturing Technician II/III - Upstream/Downstream (Fri/Sat/Sun, 6am-6:30pm)

Job Description

Job Description

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

Genezen is seeking a Manufacturing Technician II/III 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 Friday/Saturday/Sunday, 6am-6:30pm in our Lexington, MA facility.

JOB RESPONSIBILITIES

Manufacturing Operations

• 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.

Continuous Improvement

• Identify and communicate opportunities for process, procedural, and operational improvements.
• Participate in continuous improvement initiatives and problem-solving activities.

Documentation & Compliance

• 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.

Equipment & Facility Support

• 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.

Professional Development

• 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.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Ability to lift up to 40 lbs
• Criminal background check required
• Other duties as assigned

EDUCATION / CERTIFICATIONS / LICENSES

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

ON-THE-JOB EXPERIENCE

• 3-8+ 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)

SKILLS / ABILITIES

• 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.

COMPENSATION RANGE

This position may be filled at either the Technician II or Technician III level, depending on the qualifications and experience of the selected candidate. The anticipated hourly pay range is $33-$43 per hour. Actual hourly rate and level will be determined based on relevant experience, skills and education.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time.

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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 40 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

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.