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
Responsible for driving all aspects of the Analytical and Microbiological Quality Control (QC) laboratories at Genezen. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. This person is also the facility aseptic subject matter expert, including responsibilities for the environmental monitoring program. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab. ESSENTIAL JOB FUNCTIONS
Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
Monitor, maintain and continuously improve the environmental monitoring program, including conducting Environmental Monitoring Performance Qualifications as needed
Develop, implement and maintain EM trending program and metrics, including Annual Reports and evaluation of alert levels
Develop, implement and maintain an in-house isolates program
Responsible for Disinfectant Efficacy Program
Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines. - Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
Support the tech transfer of bioassays from clients to cGMP QC testing lab
Represent QC Analytical and Microbiological in client meetings and programs
Establish and maintain the stability program
Oversee LIMS development, implementation, operation, troubleshooting and maintenance
Responsible for all laboratory logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc. - Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of cell and gene products
Develop, implement and present metrics for monitoring of lab operations and stability program
Participation in client audits and regulatory inspections as SME and development of responses to observations
Responsible for hiring and development of team members, conduct performance review and disciplinary actions. - Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area
KNOWLEDGE, SKILLS, AND EXPERIENCE
| | |
| --- | --- |
| EDUCATION / CERTIFICATIONS / LICENSES | Essential/Desired |
| BS in a scientific/technical discipline | Essential |
| MS in a scientific/technical discipline | Preferred |
| ON-THE-JOB EXPERIENCE | |
| 7+ years of experience in a QC leadership position within the biological industry | Essential |
| Proven technical leadership and experience in bioanalytical methods (method 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 viral vector release assays | Preferred |
| Proven lab operations management experience | Preferred |
| 3+ years of cGXP experience | Preferred |
| SKILLS / ABILITIES | |
| Ability to maintain multiple projects and timelines | Essential |
| Strong people leadership 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
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 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.
