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
Be responsible for ensuring the successful transition of processes and technologies to and from process development labs. Will be responsible for facilitating the successful transfer of viral vector processes from clients or internal development teams to the manufacturing environment. You will play a critical role in ensuring that processes are seamlessly scaled and adapted to GMP production, enabling the production of Lentiviral, AAV, and Retroviral vectors for gene and cell therapy applications. This role will contribute to the successful delivery of viral vector products, impacting innovative therapies for patients worldwide.
ESSENTIAL JOB FUNCTIONS / DUTIES
- Ensure seamless transfer of developed processes from PD to production sites
- Write, revise, and review documents including batch records, forms, and Standard Operating Procedures (SOP)
- Create and maintain standard templates and modules used in the generation of technical documents
- Analyze process performance data from PD and manufacturing runs
- Research and investigate information to facilitate smooth transition of technology from clients
- Work with cross-functional teams to optimize processes for scale-up, ensuring efficiency, robustness, and compliance with regulatory standards.
- Initiate and manage multiple rounds of document review and ensuing revisions by proactively interacting with all levels of reviewers from subject matter expert to senior management
- Follow up with reviewers and approvers (subject matter experts) as needed
- Provide technical expertise in identifying and solving any issues that may arise during the transfer or scaling process.
- Work closely with teams in manufacturing, quality control (QC), quality assurance (QA), process development, and regulatory affairs to align goals and ensure compliance with cGMP (current Good Manufacturing Practice) requirements.
- Participate in meetings with external partners or clients to support the tech transfer process and ensure successful handoffs.
- Assist with validation activities, ensuring processes are robust and reproducible across different scales and production sites.
- Abide by GLP, GCP, and all company SOPs pertinent to the position
SPECIAL JOB REQUIREMENTS
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
EDUCATION / CERTIFICATIONS / LICENSES
- Bachelor’s or Master’s degree in a scientific discipline such as Biotechnology, Biochemistry, Chemical Engineering, or related field
ON-THE-JOB EXPERIENCE
- 2-3 years of Technology Transfer or MSAT experience and technical writing experience
- Knowledge of cGMP, GLP, and regulatory frameworks that govern the manufacturing of biopharmaceutical products
KNOWLEDGE, SKILLS AND EXPERIENCE
- Strong understanding of upstream and downstream processes, particularly in biotech, gene therapy, or biopharmaceutical industries
- Needs strong scientific knowledge, problem-solving abilities, attention to detail, and excellent communication skills to ensure the success of complex transfers from development to manufacturing
- Strong verbal/written and interpersonal communication skills, including excellent grammar and writing skills and computer proficiency
- Technical, communication, and organization skills in a teamwork environment
- Intrinsically motivated, demonstrating both initiative and accountability for tasks
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment
- Sit for long periods of time
- Ability to use personal protective equipment, if needed to be in a BSL2 environment
Movement
- Repeated hand movements, typing, use of keyboard and mouse
- 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
- 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.
Top Skills
What We Do
Founded in Indianapolis in 2014, Genezen is focused on supporting the demands of the current and future gene and cell therapy manufacturing market worldwide— making viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen offers early-phase process development, GMP lentiviral vector production, retroviral vector production, and analytical testing services, building on the company's expansive knowledge and experience in the industry and working with the nation's leading institutions. For more information, or to learn more about services offered in Genezen's new cGMP facility, please visit our website: www.genezen.com
