What are the responsibilities and job description for the Material Associate position at Genezen?

Job Description

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 receiving, processing, and accounting of raw materials in support of Genezen. Unloading / loading of materials at docks, receiving of materials, storage of material in appropriate storage zones, preparation, and shipping to customer orders .

ESSENTIAL JOB FUNCTIONS

Operate and maintain SISPQ (Safety, Identity, Strength, Purity, and Quality) of all cGMP consumables (e.g., raw material), finished product, and equipment throughout the supply chain life cycle.
Work in partnership with Quality and Purchasing to resolve any applicable quality and supply chain issues, associated with receiving, material handling, and shipping.
Demonstrate an understanding of cGMP and how it applies to the specific job function.
Verify and inspect all incoming / outgoing packaging to ensure it is in accordance with Genezen SOP's (e.g., GDocP, containments, etc.).
As required, assist other departments with inventory-related support
As required, cycle-count inventory and ensure adherence to FIFO.
As required, execute work orders (e.g., picklist, staging, closure, shipping, etc.)
Train on, sign off on, and ensure compliance with all active SOPs specific to this job function.
Assist in executing all shipments under cGMP (e.g., complete packaging, partner with carriers, prepare shipping documentation, etc.)
As required, maintain a safe workspace (e.g., cleaning, sweeping, moving obstacles etc.)
Perform routine lab maintenance and maintenance of laboratory equipment.
Maintain manufacturing material supply, primarily ensuring manufacturing spaces are adequately stocked and prepared.
Perform area sanitization and collect / dispose of waste per established procedures.

SPECIAL JOB REQUIREMENTS

Adaptability required as work schedule may change based on business needs.

Criminal background check required.

Other duties as assigned.

EDUCATION / CERTIFICATIONS / LICENSES

High school diploma

Associate Degree in Supply Chain or related field

ON-THE-JOB EXPERIENCE

1 year of experience with cGMP

2 years of Shipping and Receiving related functions in a cGMP environment

Previous experience in materials management / ERP software preferred

Prior pharmaceutical or food manufacturing / processing experience

Sit-Down Forklift 1-year experience

SKILLS / ABILITIES

Basic computer skills, including proficiency in MS Excel and Outlook, with the capability to learn in more detail

Ability to pay close attention to detail, including following instructions and procedures (SOPs, cGMP)

Must be able to multitask effectively, with a high level of organizational skills

Ability to work independently

Strong focus on customer service

Good documentation skills

Excellent verbal and written communication skills

PHYSICAL DEMANDS

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

Work Environment

Occasionally 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; 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

9 observed holidays 1 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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