Genezen

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

The QC Analyst contract role will be responsible for routine and non-routine QC sampling and testing for the quality of products manufactured for our clients. QC is responsible for execution of the Environmental Monitoring (EM) program in place to monitor Genezen's controlled manufacturing environments (cleanrooms) as well as monitoring of utility systems including Water for Injection (WFI), Pure Steam, Purified Water, Compressed Air and Gas systems. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter­departmental policies and standard operating procedures (SOPs). This position is based at Genezen’s state-of-the-art facility in Lexington, MA. This role supports daily operations as well as occasional weekend and holiday operations. This may include but is not limited to in-process monitoring and testing, lot release testing, and stability testing. Supporting activities for quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls may be required.

This position is a 2nd shift positions with a typical schedule of 1-9:30pm, Monday-Friday. There will be the occasional later evening needed for unit ops support.

ESSENTIAL JOB FUNCTIONS

• Perform routine/non-routine environmental monitoring of cGMP
• Perform routine/non-routine sampling of utility
• Perform routine/non-routine testing and review of cGMP samples in accordance with Standard Operating Procedures (Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Micro ID).
• Performs peer review with minimal errors.
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Assist with data trending and aid in compilation of trend
• Support shipment of samples to contract testing laboratories, as required.
• Support of quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls.
• Maintain QC Microbiology related systems in compliance with industry standards.
• 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

BA or BS in Microbiology or other related science

Essential

ON-THE-JOB EXPERIENCE

Minimum 0-3 years of laboratory base experience within QC testing capacity, preferably in cGMP environment.

Essential

Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+.

Essential

Understanding of industry testing requirements/standards

Essential

SKILLS/ABILITIES

Proficiency in computer applications including MS Word, Excel, and LIMS (preferred).

Essential

Good/effective communication, organizational, and time management skills with the ability to work well with others and independently

Essential

Flexibility and willingness to learn, with a proactive approach to making a positive impact

Essential

Detail Oriented

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

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
• 10 observed holidays + 2 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.

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