Quality Control Laboratory Analyst

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

Maintain lab functions and procedures, perform laboratory techniques related to viral vector production and analytics following cGMP testing guidelines. Basic laboratory techniques include materials ordering, sample organization and sample shipping, sample receiving, solution preparation, media, molecular biology techniques, aseptic cell culture techniques, and general laboratory maintenance. The position requires working independently, but also under the supervision of experienced lab personnel in quality control at our Indiana site.

ESSENTIAL JOB FUNCTIONS

• Order, organize, and maintain lab reagent material stocks
• Assist with organization and testing of samples
• Assist with managing outsource sample shipping and receiving
• Perform hands-on laboratory procedures related to viral vector production and characterization
• Maintain cGMP documentation of processing activities
• Perform routine lab maintenance and maintenance of laboratory equipment
• Train new staff members and fellow hourly employees in designated processes
• Comply with all established policies, SOPs, and cGMP guidelines
• Participate actively in SOP establishment and revisions in coordination with supervisor and Quality Assurance
• Participate in method qualification and validation activities
  
  

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

Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field

Essential

ON-THE-JOB EXPERIENCE



1+ years of relevant industry experience in QC, R&D, product development, or operations

Essential

SKILLS / ABILITIES



Excellent computer, verbal, and written communication skills

Experience with laboratory techniques including cell culture, cell-based assays, qPCR, ddPCR, flow cytometry, ELISA, and/or biostatistical analysis

Essential

Desired

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 CURES VALUE-BASED 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 principals.

Solutions 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.