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Analyst I, QC Raw Materials

Lexington, MA

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 Quality Control (QC) Raw Materials Analyst is responsible for ensuring the quality of raw materials are suitable for the intended use by the Manufacturing Department. These activities are performed in accordance with cGMP, USP, EP, and JP guidelines as well as company policies and procedures.  The QC Raw Materials Analyst I will support the day-to-day operations which include sampling, internal and external testing, controlling and releasing raw materials, as well as support QMS (Deviations, CAPA, Lab Investigations (OOS, AR, OOT), Documentation (SOPs/Forms/Material Specification), laboratory operational processes and Training.  Supports method validation/verification activities for onboarding new raw materials, as well as internal/external audits.  

ESSENTIAL JOB FUNCTIONS

  • Support routine/non-routine internal/external FIFO testing of raw materials, including sampling, inspection, internal testing and review (FTIR, pH, wet chemistry, dimensional analysis, visual inspection) in accordance with procedures/USP/EP/JP/ACS Reagent Index
  • Support shipment of raw materials to CTL for Raw Material Qualification and Process/Product testing
  • Maintaining QC raw material related systems to ensure compliance with industry standards and Regulatory requirements
  • Support Deviations, Lab Investigations (OOS, AR, OOT), and CAPA
  • Write and revise SOPs, including periodic review of GMP documents
  • Provide training to other analysts within the department within the scope of knowledge
  • Generate, Maintain, and Archive Equipment/System/Process logbooks
  • Initiate and track to completion Work Orders in BRAM
  • Supports internal and external audits as required
  • Continuous improvement of raw materials testing/sampling program, including material specifications for increased efficiency
  • Able to follow procedures trained on applying GDP/ALCOA+, to identify and promptly communicate to supervisor procedural steps that are not clear or a deviation from procedure w/ solutions.
  • Troubleshoot instrument/method/operational system error w/ guidance.
  • Recognizes and escalates to supervisor when support is needed to complete assigned workload.

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

  • A minimum of BS in Chemistry or other related science.
  • Minimum of 1 - 3 years of relevant GMP laboratory experience in pharma/biotech company
  • Able to work in a fast-paced environment, manage multiple priorities, complating assigned tasks on time and prioritize with guidance from supervisor
  • Solid understanding of USP/EP/JP for Raw Materials, as well as knowledgeable in cGMP/ICH/FDA/EU regulations and guidelines
  • Excellent technical experience and functional knowledge of related equipment
  • Proficient in Microsoft applications (Word, Excel, PowerPoint)
  • Strong communication, organizational, and cross-functional skills are required
  • Capable of working autonomously

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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This position requires a criminal background check and drug screening.

Genezen is an Equal Opportunity Employer.

Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

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