Quality Control Scheduler

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

We are seeking a detail-oriented and proactive Quality Control Scheduler to oversee and optimize the scheduling and management of various quality control operational activities within our cGMP biotechnology environment. This role will be critical in ensuring the timely execution of testing and review to meet client quality agreements while maintaining compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will have extensive experience in a cGMP QC laboratory, exceptional project management skills, and a strong collaborative mindset.

ESSENTIAL JOB FUNCTIONS

Sample Tracker and Scheduling Management:

Oversee the scheduling and management of In-Process, Release, Stability Testing, Method Training, Method Transfer, and Method Qualification/Validation using SQC scheduling tool.

Coordinate Instrument/Equipment PQ and Excel Spreadsheet Validation.

Manage execution of Critical Reagent Qualifications, including Reference Standard.

Internal Coordination and Communication:

Interface with internal resources and provide routine updates on testing to internal customers and QA.

Performance Management:

Oversee QC Key Performance Indicators (KPIs) and provide periodic updates to management.

Compliance and Audits:

Support internal and external compliance and regulatory audits, ensuring adherence to industry standards and regulations.

Process Improvement:

Generate and support continuous improvement initiatives to streamline lab processes and enhance operational efficiency.

Cross-Functional Support:

Assist in cross-functional lab management processes, such as data archival and Result Summary/CoA generation.

Back-up support testing and review of assays trained on maintaining proficiency.

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

Bachelor’s Degree in a relevant field with 5+ years of experience

Essential

Master’s Degree with 2+ years of experience in a GMP biotechnology discipline

Desired

ON-THE-JOB EXPERIENCE

Proven experience in a cGMP QC laboratory setting (analytical, bioanalytical, or microbiology) with project and time management skills.

Desired

Demonstrated ability to manage multiple competing priorities and aggressive timelines while understanding risk management and tolerance.

Desired

Knowledge of Quality Systems, USP, FDA, and ICH regulations, and a thorough understanding of industry testing requirements and 21 CFR Part 11.

Desired

Experience with process improvement.

Desired

SKILLS / ABILITIES

Strong communication skills with a collaborative approach, fostering open communication and cooperation between stakeholders.

Essential

Proficiency in Microsoft Word and Excel.

Desired

Agile with excellent communication and organizational skills, capable of working effectively both independently and as part of a team.

Desired

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

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.