Stability Manager, Quality Control

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 Quality Control Technical Services (QCTS) team manages the lifecycle of analytical methods, including method transfer and validation, stability programs, reference standards, critical reagents, product specifications, and computer systems validation. The Manager, QC Stability provides leadership and strategic oversight of the stability programs from early phase through commercialized programs. This role ensures regulatory compliance, analytical excellence, and effective cross-functional collaboration to maintain product quality throughout the product lifecycle

ESSENTIAL JOB FUNCTIONS

Govern the Stability Program on behal f of clients across all early phase, and commercial programs for DS, DP, and diluents

Ensure compliance with Quality Agreements and global regulatory expectations

Maintain and oversee the Stability Master Planner

Monitor and publish stability KPIs

Supervise, mentor, and develop team members.

Own quality documentation including deviations, CAPAs, and change controls related to stability

Manage the revision and approval SOPs, protocols, and reports

Conduct audits of stability studies and processes

Verify data for accuracy and compliance

Summarize and interpret stability data and generate stability trend analysis reports

Partner with cross-functional teams for execution of stability studies

Identify and implement operational improvements

SPECIAL JOB REQUIREMENTS

Proven leadership and cross-functional collaboration skills

Ability to manage competing priorities under pressure

Highly organized with strong problem-solving skills

Clear professional communication and presentation skills

Commitment to quality, integrity, and continuous improvement

Prior CDMO experience a plus

Adaptability required as work schedule may change based on business needs

Criminal background check required

Other duties as assigned

EDUCATION

Education Level : Master’s Degree in science - related field

ON-THE-JOB EXPERIENCE

8+ years of industry experience in CDMO

Experience managing stability programs for cell/gene therapy products

Strong understanding of cGMPs and global regulations

Experience managing deviations, CAPAs, and change controls

Experience with analytical methods such as potency assays, ELISA, ddPCR, qPCR, SEC-HPLC, and CE-SDS

SKILLS/ABILITIES

Prior experience working in a CDMO environment

8+ years working in a Good Manufacturing Practices (GMP) environment

Subject matter expert in Good Documentation Practices (GDP)

Excellent computer literacy (MS Word, Excel, SmartSheets)

Excellent project management tools (MS project, SmartSheets)

Excellent executive communication skills, both written and oral

PAY RANGE: The annual salary range for this position is $130,000-$150,000.

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

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 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

C ommitted to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals.

S olutions 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

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.