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Manufacturing Specialist II

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 MFG Specialist in this role will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The MFG Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.  

This position is located in Lexington, MA and reports to the MFG Compliance and Improvement Manager.

ESSENTIAL JOB FUNCTIONS

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines
  • Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change.
  • Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events.
  • Identifies and drives Manufacturing corrective and/or preventative actions.
  • Provide Manufacturing support for tech transfers
  • Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing.
  • Participates on cross functional teams to drive complex manufacturing operations changes or improvements
  • Supports document revisions and/or document management including batch production records and manufacturing procedures
  • Performs training with staff on the floor
  • Provides expertise for processing technology (chromatography, filtrations, digital systems, etc…)
  • Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
  • Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation.
  • Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance
  • Reviews the work of others and provides feedback
  • Creates and presents trending and metrics reports
  • Participates in equipment start-up, commissioning, and validation activities
  • Works in a manner that requires consistent exercise of discretion and judgment

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

BS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experience

Essential

ON-THE-JOB EXPERIENCE

 

Minimum 2-3 years related industry experience in related field

Essential

Experience with owning, investigation and writing deviations, creating and executing CAPAs, and writing and managing Change controls

Essential

Experience in biomanufacturing unit operations (USP and/or DSP)

Essential

Experience performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc.)

Essential

Able to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures

Essential

SKILLS / ABILITIES

 

Ability to apply systems thinking as part of a problem-solving

Essential

Demonstrates industrial empathy when working with stakeholders

Essential

Detail oriented and able to self-organize

Essential

Able to communicate in a professional way on diverse levels and channels

Essential

Takes the initiative to own and resolve issues

Essential

Good technical writing and oral communication skills

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 GMP clean room environment with personal protective equipment/aseptic gowning
  • Regularly required to work around equipment 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 loud noise levels
  • Spending time on the floor during activity execution 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 40 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
  • 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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