Manufacturing Technician I/II/III (2nd Shift)

Genezen; Lexington (MA); On-site; USD 40,000 - 80,000; Full time

Job summary

Join a rapidly growing company in the gene therapy field as a Manufacturing Technician. This role involves performing critical manufacturing operations, ensuring compliance with cGMP standards, and collaborating with various departments. You will be responsible for executing routine and non-routine production tasks, managing equipment, and maintaining a safe work environment. With a commitment to innovation and excellence, this position offers a rewarding opportunity to contribute to groundbreaking therapies that can change lives. If you are a dedicated problem solver looking to make a difference, this role is for you.

Benefits

Paid vacation days

401(k) plan with company match

Choice of several healthcare plans

FSA and HSA programs

Employer-paid basic term life insurance

Voluntary disability insurance

Qualifications

• High School Diploma required; Associate’s or Bachelor’s in Life Sciences/Engineering preferred.
• 2-4 years related cGMP industry experience is essential.

Responsibilities

• Perform cGMP manufacturing operations and maintain documentation according to SOPs.
• Manage equipment, perform cleaning, and support facility-related projects.

Skills

Aseptic techniques

Troubleshooting

Documentation writing

Communication skills

Process-oriented thinking

Education

High School Diploma

Associate’s Degree in Life Sciences/Engineering

Bachelor’s Degree in Life Sciences/Engineering

Job description

Manufacturing Technician I/II/III (2nd Shift)

Lexington, MA

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

At Genezen, 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 committed to empowering our employees to be their best and making Genezen a rewarding place to work.

JOB SUMMARY

The Manufacturing Technician 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 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.

ESSENTIAL JOB FUNCTIONS

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records, and Solution prep records. Primary responsibilities include:

• Attend daily meetings including shift handoff and ensure relevant information is shared between shifts.
• Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state.
• Maintain orderliness of the process area and stock the production area with supplies.
• Demonstrate 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.
• Work holidays and overtime as needed to support the manufacturing process.

This individual will manage equipment and support facility-related projects by:

• Performing scheduled cleaning of equipment.
• Performing standardization of equipment.
• Supporting product changeover activities.
• Supporting equipment and process qualifications if needed.
• Escalating work requests to Senior or Lead Technicians for submission in the work request management system.

SPECIAL JOB 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.
• Preferably working experience in a comparable position in an industrial organization.
• 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.

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

High School Diploma, Associate’s Degree in Life Sciences/Engineering, or Bachelor’s Degree in Life Sciences/Engineering.

ON-THE-JOB EXPERIENCE

2-4 years related industry experience.

SKILLS / ABILITIES

• Has a process-oriented way of thinking and working.
• Is self-organized.
• Can communicate professionally on diverse levels and channels.
• Is capable of taking initiative when necessary.
• Has a flexible attitude in a challenging environment.
• Is intrinsically motivated.

PHYSICAL DEMANDS

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

• 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 20 pounds.
• Rarely 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

• Committed to Science: We are committed to scientific excellence, 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.
• Resilience & Grit in operations: We are committed to overcoming challenges and 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 partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure.
• 401(k) plan with company match up to 6% of salary, vested immediately.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Employer-paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident insurance.

ADDITIONAL DETAILS

• 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.