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

Responsible for routine performance of upstream and downstream manufacturing operations including advanced laboratory techniques related to viral vector production and analytics as well as basic laboratory functions. Responsibilities and laboratory techniques required for this position include aseptic technique, preparing solutions and media, molecular biology techniques, cell culture techniques, chromatography, TFF and general cleanroom sanitization/area maintenance. The position requires working independently, but also under the supervision of the Manufacturing Manager and experienced personnel.

ESSENTIAL JOB FUNCTIONS

  • Execute hands on manufacturing processes related to viral vector production including upstream and downstream GMP manufacturing tasks under the guidelines of established procedures and batch records
  • Perform manufacturing activities related to tissue culture and maintenance of mammalian cell lines
  • Perform manufacturing activities related to different flatware and adherent and suspension bioreactors
  • Assist with process development and validation of manufacturing processes and equipment
  • Maintain manufacturing material supply, primarily ensuring manufacturing spaces are adequately stocked and prepared
  • Assist in the maintenance of laboratory equipment and laboratory support operations
  • Assist in the creation, review, and revision of SOPs, batch records, and forms in coordination with management and Quality Assurance
  • Follow detailed instructions with a high level of focus and attention to detail
  • Complete documentation accurately and in a timely fashion
  • Maintain up to date training status
  • Use, clean, and maintain laboratory spaces and manufacturing equipment
  • Assist in troubleshooting of upstream and downstream manufacturing issues
  • Train new staff members and fellow employees in designated processes
  • Comply with all established policies and SOPs
  • Perform safety inspections and maintain a safe working environment
  • Use industrial equipment such as pallet jacks
  • Perform area sanitization and collect/dispose of waste per established procedures
  • Help collect process data for metrics/trending
  • Assist in tasks required to be performed in a BSL-1, -2, or -3 environment.
  • Contribute to the support, optimization, and improvements of GMP products
  • Assist in specification development and review via Corrective and Preventive Actions (CAPA) and/or change controls
  • Work as a team with Process Development, Quality Assurance, and other departments as needed

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

BS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experience

Essential

ON-THE-JOB EXPERIENCE

 

Minimum 1 year of post-graduation experience in related field

Essential

Experience operating in a GMP laboratory using aseptic technique and risk mitigation strategies

Essential

Experience with mammalian cell culture in 2D and/or 3D platforms

Essential

Experience in the cell and gene therapy manufacturing, specifically viral vectors

Desired

 

 

SKILLS / ABILITIES

 

Ability to work independently with minimal supervision as well as working effectively as part of a team

Essential

Strong verbal, written, and interpersonal communication skills

Essential

Able to adapt quickly to changing ideas, responsibilities, strategies, and other processes

Essential

Willing to work in an environment where individual initiative, collaboration, and accountability are valued

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 BSL 2 environment with personal protective equipment/aseptic gowning
  • Regularly required to work around large machinery 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 extremely loud noise levels

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 VALUE-BASED COMPETENCIES

Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.

Flexibility
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.

Team Focus
Work together; succeed together; fail together.

Integrity
Do the right thing, on time, every time.
Speak up when needed.
Exercise respect.

Inclusion
Embrace the unique viewpoint of each individual.
Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure, and paid sick time
  • 8 observed holidays + 1 floating holiday
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Choice of six healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident 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 is located in Fishers, Indiana.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • 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 is located in Fishers, Indiana, 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.

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