Manufacturing Technician I/II/III (Contract)

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.

GENEZEN'S BENEFITS

Paid vacation days, amount based on tenure

Paid sick time

10 observed holidays + 2 floating holiday + 1 volunteer day

401(k) plan with company match up to 6% of salary

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 qual