Manufacturing Technician II/III - Upstream/Downstream (M-F, 7am-3:30pm)

About the role

Genezen is seeking a hands-on Manufacturing Technician II/III to play a key 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 position is responsible for performing routine and non-routine manufacturing operations in a cGMP environment, including process execution, in-process controls, equipment operation, and documentation. You will work closely with MSAT, QC, QA, Engineering, and Validation teams to ensure safe, compliant, and high-quality manufacturing operations.

The position is based in our Lexington, MA facility with a schedule of Monday-Friday, 7am-3:30pm.

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

Requirements

• High School, Associates, or Bachelor's Degree, preferably in Life Sciences/Engineering field.
• 3-8+ years prior manufacturing experience, preferably in a comparable position within an industrial organization.
• Hands-on experience in writing and reviewing documentation.
• Experience in (bio)-manufacturing unit operations (USP and/or DSP).
• Adaptability required as work schedule may change based on business needs.
• Ability to lift up to 40 lbs.
• Criminal background check required.

Skills

• Excellent written, verbal, and interpersonal communication skills with the 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.

Competencies

• Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
• Urgency in action for the patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
• Resilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.
• Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.
• Solutions driven for our partners: We are committed to being a proactive, collaborative, creative, and open-minded partner.

Pay

This position may be filled at either the Technician II or Technician III level, depending on qualifications and experience. 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.

Benefits

• Paid vacation days, amount based on tenure.
• Paid sick time.
• 10 observed holidays + 2 floating holidays + 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.

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 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 email.