From Genezen's posting. “We” and “our” refer to the employer.
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 supporting projects from advanced laboratory techniques related to viral vector production and analytics to routine performance of upstream and downstream manufacturing operations including aseptic cell culture technique, preparing solutions and media, molecular biology techniques, chromatography, TFF and general cleanroom sanitization/area maintenance. The position requires working independently, but also under the supervision of experienced personnel.
ESSENTIAL JOB FUNCTIONS
Execute hands on project work from process development through manufacturing related to viral vector production including upstream and downstream GMP manufacturing tasks under the guidelines of established procedures and batch records
Perform hands on laboratory procedures related to viral vector production and characterization
Perform daily operations in the scale-up, production, harvest, clarification, purification, and fill/finish of retro, lenti, and AAV viral vectors.
Execute production activities including cell thawing, cell passaging, bioreactor inoculation, clarification filtration, chromatography, tangential flow filtration, sterile filtration and filling of viral products following GMP guidance and according to applicable batch records.
Maintain appropriate GDP documentation of processing activities
Perform routine lab maintenance and maintenance of laboratory equipment
Assist in the development of general and technical SOPs and with the creation of client specific procedures and batch records
Maintain manufacturing material supply, primarily ensuring manufacturing spaces are adequately stocked and prepared
Assist in the maintenance of laboratory equipment and laboratory support operations
Follow detailed instructions with a high level of focus and attention to detail
Complete documentation accurately and in a timely fashion
Maintain up to date training status
Use, clean, and maintain lab and manufacturing equipment
Assist in troubleshooting of upstream and downstream manufacturing issues
Cross train new staff members and fellow employees in designated processes
Comply with all established policies and SOPs
Perform safety inspections and maintain a safe working environment
Participate actively in continuous improvement activities and SOP revisions in coordination with management and Quality Assurance
Perform area sanitization and collect/dispose of waste per established procedures
Help collect process data for metrics/trending
Use and maintenance of cGMP equipment
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
Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field
Strongly Desired
ON-THE-JOB EXPERIENCE
1-4 years of relevant cleanroom GMP industry experience in R&D, product development, or operations
Essential
Upstream Cell culture experience with mammalian or insect cell culture in adherent or suspension platforms. Experience with bioreactor inoculation and harvest
Desired
Experience with downstream purification techniques including Affinity Chromatography, Anion Exchange Chromatography, Ultracentrifugation, Nanofiltration, Tangential Flow Filtration, Sterile Filtration, and Fill/Finish.
Desired
Aseptic operations in a Class 7 (Grade C) or higher cleanroom setting
Desired
SKILLS / ABILITIES
Excellent computer, verbal, and written communication skills
Essential
Ability to work independently with minimal supervision as well as working effectively as part of a team
Essential
Able to adapt quickly to changing ideas, responsibilities, strategies, and other processes
Essential
Willing to work in an environment where individual initiative, collaboration, and accountability are valued
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
Movement
Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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 25 pounds
Occasionally lift and/or move up to 50 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
C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
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.
Employer application notice
Equal opportunity and accommodations
Genezen is an Equal Opportunity Employer.
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