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
The Manufacturing team 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.
JOB RESPONSIBILITIES:
This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.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
- Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
- Lead troubleshooting activities and coach team members through use of SOPs; escalate process issues to Lead or Supervisor
- Initiate minor/major deviations
- Execution 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, Solution records, Log Books 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
- Escalate training gaps and provide training program improvement ideas to Training Lead
- Contribute to significant process improvements with cross-functional teams
- May be required to work at least four holidays in the calendar year
This individual will manage equipment and support facility related projects by:
- Create work requests as needed
- 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 cross-functional team in the execution of equipment qualification and process validation
Comfortably able to lift up to 40lbs Staff Technical Training and Development:
- Request new logbooks as needed
- Obtain QC testing results as needed to support BPR closure
- Propose document revisions and support improvements as needed
- Develop and maintain personal development plan
- Provide annual performance self-assessment
SPECIAL JOB REQUIREMENTS
- 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
Essential/Desired
HS DiplomaEssentialAssociate's or Bachelor's degree in Life Sciences/Engineering Desired
ON-THE-JOB EXPERIENCE
4-6 years related industry experienceEssential
SKILLS / ABILITIES
Has a process-oriented way of thinking and working EssentialDetail orientedEssentialSelf-organizedEssentialAble to communicate in a professional way on diverse levels and channelsEssentialCapable of taking initiative when necessary EssentialMaintains a flexible attitude in a challenging environment EssentialIntrinsically motivated Essential
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:Work Environment
- Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning
- 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
- Spending time on the floor during activity execution 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 20 pounds
- Occasionally 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 ScienceWe 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 patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe 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.
