QC Analyst II - Analytical

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 II 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 evening 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 on 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.
• 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, Potency Assay, TCID50 and other Cell based assays)
• Performs peer review as SME of assay data with minimal errors.
• Able to work effectively in internal/cross-functional teams as an active member. Train and execute on 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.

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 | | ------------------------------------------------------------------------------------------------------------------ | --------------------- | | 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 | | 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 | | SKILLS/ABILITIES | | | Computer literacy (MS Word, Excel, and LIMS) | Essential | | Good/effective communication and organizational skills with the ability to work well with others and independently | Essential |

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; 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 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 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.