QC Analyst – Analytical (Contractor)

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 will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs).  This position is based at Genezen’s new state-of-the-art facility in Lexington, MA.  This role supports the daily and occasional weekend operations within the Quality Control group via execution of analytical testing and Quality Systems.  This includes but is not limited to in-process testing, lot release testing, and stability testing.  Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls.  These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

ESSENTIAL JOB FUNCTIONS

•  Perform routine/non-routine testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, HPLC, Osmolality, Western Blot, etc.)
• Performs peer review with minimal errors.
• Able to work effectively in internal/cross-functional teams as an active member. Train and execute assays cross-functionally to support deadlines for release.
• Participate in equipment validation, method transfer/validation, and special protocol execution
• Responsible for protocol and report generation/revision/review, as required.
• Strong understanding of regulations, able to apply to any situation, and identify deficiencies w/ some guidance.

ADDITIONAL RESPONSIBILITIES

• 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 Chemistry/Biochemistry or other related science

Essential

ON-THE-JOB EXPERIENCE

 

Minimum 0-5+ years of laboratory base experience within QC testing capacity, preferably in cGMP environment.

Essential

SKILLS/ABILITIES

 

High proficiency in q-PCR and HPLC methods and analysis

Essential

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

Essential

Understanding of industry testing requirements/standards

Essential

Computer literacy (MS Word, Excel, and LIMS)

Essential

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

 

 

PHYSICAL DEMANDS

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

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; 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 10 pounds
• Rarely lift and/or move up to 25 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 ti