Manufacturing Technician III

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

Manufacturing performs all required process steps and in process controls, in close collaboration with Process Development, QC, QA, Engineering and Validation.

With limited supervision this individual will 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. Will support engineering and validation activities.

ESSENTIAL JOB FUNCTIONS

Independently perform manufacturing of Genezen's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements.

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps.

Primary responsibilities include the following :

• Attend / run daily morning meetings
• 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
• Demonstrating general knowledge of aseptic techniques
• Perform troubleshooting activities according to SOPs
• Execute routine and non-routine production operations according to MFG schedule
• Informing management of events impacting schedule
• 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
• Communicate cross-functionally for sample submission and process monitoring as required per BPR / SLR
• Carry out work in a safe manner, notifying management of safety issues and risks
• Provide Process & Equipment Training as a Qualified Trainer
• Maintain up-to-date training folder for applicable processes
• May be required to work at least four holidays in the calendar year

This individual will manage equipment and support facility related projects by

• Act as subject matter expert for improvement projects
• Perform scheduled cleaning of equipment
• Assembly and disassembly of process equipment
• Perform standardization of equipment
• Perform 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

Working with supervision this individual will

• Request new logbooks as needed
• Propose document revisions and support improvements as needed
• Escalate process improvement ideas and support as necessary
• Develop and maintain personal development plan
• Provide annual performance self-assessment

KNOWLEDGE, SKILLS AND EXPERIENCE

• Normally requires a high school diploma and 4-6 years related cGMP industry experience or an Associate's Degree in Life Sciences / Engineering field with 3 years of cGMP Manufacturing experience or Bachelor's degree in life Sciences / Engineering field with 1-3 years of cGMP experience
• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially 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

Core competencies

• Has process-oriented way of thinking and working
• Is detail oriented
• Is self-organized
• Is able to communicate in professional way 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 :

Work Environment

• Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to loud noise levels
• Occasionally required to do work outdoors, including roof top mechanical units
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

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 25 pounds
• Occasionally lift and / or move up to 50 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
• 9 observed holidays + 1 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• 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.