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Cell Therapy Process Development Jobs in Indiana

Genezen

Associate, Quality Operations

Indianapolis, IN · On-site

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.

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Cell Therapy Process Development information

What are the key skills and qualifications needed to thrive as a cell therapy process development professional?

To thrive in Cell Therapy Process Development, you need a solid background in cell biology, biotechnology, or a related field, often supported by a relevant degree and experience with cell culture techniques. Familiarity with bioprocessing equipment, Good Manufacturing Practice (GMP) regulations, and analytical tools such as flow cytometry and PCR is typically required. Strong problem-solving skills, attention to detail, and effective teamwork enhance performance in this collaborative and innovative environment. These competencies ensure the safe and efficient development of cell therapies, meeting rigorous quality standards and advancing clinical applications.

What are some typical challenges faced by professionals in cell therapy process development, and how are they addressed?

Professionals in Cell Therapy Process Development often encounter challenges such as scaling up production processes from laboratory to clinical or commercial scale while maintaining product quality and consistency. Additional hurdles include adhering to strict regulatory requirements and managing complex collaborations across cross-functional teams, like quality assurance, regulatory affairs, and manufacturing. These challenges are typically addressed through rigorous process optimization, thorough documentation, and ongoing communication with stakeholders to ensure that all aspects of the process meet industry standards and regulatory expectations.

What is the difference between Cell Therapy Process Development vs Cell Therapy Manufacturing Specialist?

AspectCell Therapy Process DevelopmentCell Therapy Manufacturing Specialist
CredentialsTypically requires a degree in biology, biochemistry, or biomedical engineering; certifications in GMP or cell therapy are commonSimilar credentials; often holds degrees in related fields and GMP certifications
Work EnvironmentResearch labs, development facilities, early-stage process optimizationManufacturing plants, production floors, quality control labs
Industry UsageFocuses on developing and optimizing cell therapy processesInvolved in large-scale production and process execution

Cell Therapy Process Development professionals focus on designing and refining cell therapy procedures, while Cell Therapy Manufacturing Specialists handle the production and quality assurance in manufacturing settings. Both roles require similar educational backgrounds and certifications but differ mainly in their work environment and specific responsibilities.

What is cell therapy process development?

Cell Therapy Process Development refers to the design, optimization, and scaling up of manufacturing processes for cell-based therapies, such as CAR-T cells or stem cell products. Professionals in this field work on translating laboratory research into reproducible, efficient, and safe production methods that meet regulatory standards. This involves working with cell culture techniques, bioreactors, quality control, and process validation to ensure that therapies can be produced consistently for clinical and commercial use. The goal is to develop robust processes that deliver safe and effective cell therapies to patients.
What are popular job titles related to Cell Therapy Process Development jobs in Indiana? For Cell Therapy Process Development jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Cell Therapy Process Development jobs in Indiana look for? The top searched job categories for Cell Therapy Process Development jobs in Indiana are:
Cell Therapy Process Development jobs near you
Infographic showing various Cell Therapy Process Development job openings in Indiana as of August 2026, with employment types broken down into 71% Full Time, and 29% Part Time. Highlights an 100% In-person job distribution.

Associate, Quality Operations

Genezen

Indianapolis, IN

Full-time

Re-posted 19 days ago

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.

PURPOSE

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

ESSENTIAL JOB FUNCTIONS / DUTIES

  • Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
  • Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
  • Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
  • Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
  • Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
  • Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
  • Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
  • Review, assess, and release quality control tests and Certificates of Analysis
  • Review and approve executed batch records. Provide guidance and support to departments on errors to ensure error reduction.
  • Assist in the final disposition of master cell banks and viral vector products.
  • Review and approve qualification/validation protocols and reports and technology transfer reports.
  • Provides site GMP and GDP training (annually, for new-hires, and as needed).
  • Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
  • Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
  • Drive Quality Events to closure within on-time closure deadlines.
  • Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products,
  • Review and approve Master Batch Records.
  • Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed.
  • Review and approve Stability Protocols.
  • Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas
  • Initiate, review, approve and monitor Change Management activities
  • Work with the other functional areas to give guidance on use of quality systems.
  • Assist the Lead Auditors to perform site internal audits.
  • Lead and/or support customer audits and regulatory inspections by participating in either front or back room.
  • Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations

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

Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials

Essential

Familiarity of eQMS systems such as Veeva

Desired

Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms

Desired

ON-THE-JOB EXPERIENCE

3-5 years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role

Essential

Experience working in with early phase clinical trial production and testing

Desired

Previous experience with a startup CDMO and/or in the field of Gene Therapy

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, deviation/nonconformance management, training, and problem solving

Essential

Work independently and be self-motivated

Essential

Proven ability to work cross-functionally to achieve business outcomes

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
  • 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

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
  • 10 observed holidays + 2 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary
  • 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.