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
Direct the establishment of analytical methods in the Analytical Development (AD) lab. This individual will be responsible for developing and qualifying/validating analytical methods for viral vectors and transferring these processes from the AD lab to the QC lab in accordance with cGMP standards. The role requires collaboration with cross-functional teams to establish and implement best regulatory and laboratory practices and to lead the execution of complex experiments at our Indiana site.
ESSENTIAL JOB FUNCTIONS
- Develop, optimize, and standardize analytical methods for viral vector characterization, including Lentiviral (LVV), Retroviral (RVV), and Adeno-associated Virus (AAV) vectors.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.
- Implement best laboratory practices to maintain consistency, accuracy, and reliability of analytical results.
- Act as SME for the platform analytical process.
- Maintain familiarity with current analytical methods, including Flowcytometry, ELISA, qPCR based assays
- Maintain familiarity with current equipment used in Analytics lab
- Develop, Qualify/Validate analytical methods to support the cGMP testing
- Establish a robust process transfer protocol to move analytical methods from the AD lab to the QC lab and or Client laboratories.
- Help train AD/QC associates and technicians and work closely with other departments, assisting in project planning
- Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of biological products
- Advise site and quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued
- Execute research timelines to meet program and corporate objectives
- Deal with abstract and concrete variables in situations where only limited standardization exists
- Maintain high quality deliverables and open communication, creating a collaborative working environment
- Contribute to a collaborative, creative and rigorous culture of scientific discovery
- Provide monthly reports to department head
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 degree in scientific/technical discipline
Essential
ON-THE-JOB EXPERIENCE
3-5 years of CRO/CDMO experience in bioanalytical methods (development, validation, and transfer); methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays and flow cytometry-based assays
Essential
Familiarity with bioanalytical assays
Preferred
Proven assay qualification/validation experience
Preferred
3+ years of cGXP experience
Preferred
Experience with documentation and reporting of results using electronic lab notebooks
Preferred
SKILLS / ABILITIES
Strong people leadership skills
Essential
Ability to interpret and analyze data, define problems, establish facts, draw valid conclusions and make decisions
Essential
Ability to maintain multiple projects and timelines
Essential
Excellent verbal and written communication skills
Essential
Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills
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
- Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required
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 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.
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
