QC Scientist - Critical Reagents

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QC Scientist - Critical Reagents

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 QC Scientist - Critical Reagents is responsible for overseeing all reference standards and other critical reagents in line with internal SOPs and ICH guidelines. This individual will work collaboratively with QC Operations, Analytical Development, and Quality Assurance in support of clinical pipeline and commercial products. This position requires strong leadership skills, statistical and technical knowledge, and a commitment to quality and compliance

ESSENTIAL JOB FUNCTIONS

• Oversee the Critical Reagents and Materials function.
• Oversee the day-to-day operations of the GC QC Technical Services group.
• Provided operational oversight for critical reagent and materials management across the quality organization.
• Develop and maintain robust systems for the qualification, monitoring, tracking and storage of critical reagents and materials.
• Collaborate with cross-functional groups to ensure the continued supply of qualified reagents and materials.
• Act as the primary point of contact for the monitoring, tracking, and storage of critical reagents and materials.
• Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials.
• Represent Quality Control on project teams and in meetings as required.
• Authors and reviews standard operating procedures, protocols, and reports as required.
• Manages the implementation/maintenance/continuous improvement of Quality Systems as required.
  
  

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 in Life Sciences or Engineering

Essential

ON-THE-JOB EXPERIENCE

8 years of pharma/biotech industry experience

Essential

Well versed in cGMP/ICH/FDA/EU regulations and guidelines

Essential

Large molecule, gene or cell therapy experience is required.

Expertise in reference standards programs, including ICH regulations and quality control methods.

Essential

Strong background in biostatistics for evaluation comparability and qualification of new reference standards and control reagents.

Desired

Experience in Quality Control within the biological pharmaceutical industry.

Desired

Essential

Proficiency in writing SOPs, qualifications protocols, and reports.

Familiarity with statistical software (JMP).

SKILLS / ABILITIES

Excellent analytical and problem-solving skills

Essential

Must possess excellent communication and organizational skills

Essential

Cross functional collaboration ability to work well with diverse groups

Essential

Ability to manage multiple activities with challenging timelines

Essential

Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)

Essential

Effective oral and written communication skills

Essential

Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards

Essential

Exhibits highest integrity and committed to ethics and compliance standards

Essential

Open and transparent in sharing data and information

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.