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.

PURPOSE

Be an integral part of the Quality team by providing quality assurance oversight and leadership to operations, manufacturing, and quality control activities.  Address terms of systems quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

  • Assist in the maintenance of quality systems including a robust and continuous quality improvement system compliant with GMP and applicable to cell and gene therapy products used in early phase clinical trials.
  • Quality subject matter expert, providing training, oversight, collaboration and approval on all Quality Management Systems activities and outputs, including but not limited to electronic change control, quality events, deviation investigations and CAPAs in Veeva Vault QMS.
  • Develops and prepares quality management system metrics for Quality Management Review.
  • Provides support in the preparation, conduct, and follow-up activities associated with regulatory inspections and client audits
  • Quality review and approval of validation protocols, executed validation packages, and summary reports.
  • Quality partner on client tech transfer teams to successfully onboard new clients and new projects, including materials, suppliers, equipment, processes, master records, and additional support required.
  • Support internal and external (supplier) audit program as a qualified auditor, including writing audit reports and following up on corrective actions and commitments. 

SPECIAL JOB REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check and drug screen required
  • Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

Bachelor’s degree in science or related field

Essential

In depth knowledge of cGMP FDA and EU regulations, and ICH guidelines

Essential

Familiar with regulatory guidelines for early phase clinical trials

Essential

Certified Quality Auditor or Certified Pharmaceutical GMP Professional

 

Desired

ON-THE-JOB EXPERIENCE

 

Minimum of 3-5 years of working experience in Pharma, Biologics, CGT industry in a Quality Assurance role

Essential

Previous experience reviewing and approving quality system reports – deviation, CAPA, change control

Essential

Previous experience reviewing validation protocols and reports

Desired

Previous experience with product/process tech transfer

Desired

Previous experience in the field of Gene Therapy

Desired

Previous experience at a fast-paced CDMO.

Desired

SKILLS / ABILITIES

 

Manage multiple projects, set priorities, and work in fast-paced environment

Essential

Communicate confidently and effectively with management, peers, and key stakeholders

Essential

Demonstrate effectiveness in task completion, decision-making, empowerment of others, and problem solving

Essential

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

Work Environment

  • Occasionally exposed to loud noise levels
  • Position can be a combination of remote and on-site
  • Regularly sit for long periods of time

Movement

  • Frequently required to stand; sit; 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 10 pounds
  • Occasionally lift and/or move up to 25 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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