Manufacturing Technician I/II/III (Contract)

Genezen; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Health care plans

FSA/HSA programs

Employer-paid life insurance

Disability insurance

Job summary

Genezen in Indianapolis, IN, is seeking a hands-on scientist to support viral vector production and analytics, from upstream/downstream GMP manufacturing to aseptic cell culture and fill/finish operations. The role requires independent work under supervision, attention to detail, and collaboration with quality assurance to maintain cGMP documentation, SOPs, and continuous improvement.

Experience with scale-up, chromatography, TFF, and GMP batch records is valued; the team emphasizes initiative

Qualifications

• Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field.
• 1-4 years of relevant cleanroom GMP industry experience in R&D, product development, or operations.
• Aseptic operations in a Class 7 (Grade C) or higher cleanroom setting.
• Experience with upstream/downstream viral vector production and purification techniques.

Responsibilities

• Execute hands on project work from process development through manufacturing related to viral vector production under established procedures and batch records.
• Perform hands on laboratory procedures related to viral vector production and characterization.
• Perform daily operations in scale-up, production, harvest, clarification, purification, and fill/finish of retro, lenti, and AAV viral vectors.
• Maintain appropriate GMP documentation of processing activities.
• Assist in development of SOPs and client specific procedures and batch records.

Skills

Upstream cell culture

Downstream purification

Bioreactor inoculation

Aseptic technique

GMP manufacturing

cGMP documentation

Chromatography

Tangential Flow Filtration

Fill/finish

SOP development

Laboratory measurements

Education

Associate or BS degree in Biology/Biochemistry/Molecular Biology

Job description

Indianapolis, IN

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

Manypeople 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

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

Upstream Cell culture experience with mammalian or insect cell culture in adherent or suspension platforms. Experience with bioreactor inoculation and harvest

Experience with downstream purification techniques including Affinity Chromatography, Anion Exchange Chromatography, Ultracentrifugation, Nanofiltration, Tangential Flow Filtration, Sterile Filtration, and Fill/Finish.

Aseptic operations in a Class 7 (Grade C) or higher cleanroom setting

SKILLS / ABILITIES

Excellent computer, verbal, and written communication skills

Ability to work independently with minimal supervision as well as working effectively as part of a team

Able to adapt quickly to changing ideas, responsibilities, strategies, and other processes

Willing to work in an environment where individual initiative, collaboration, and accountability are valued

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

• 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
• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed toscientific 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
• 401(k) plan with company match up to 6% of salary
• Choice of several healthcare plans
• FSA and HSA programs
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident 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.