Stability Manager, Quality Control

JOB SUMMARY

The QC Senior/Principal Scientist for Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department within our CDMO facility. The individual in this role will work collaboratively with new and current clients, analytical development team, quality control, manufacturing and quality assurance. Lead transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen’s services and commercial products in compliance with company policies and procedures and regulatory guidelines.

ESSENTIAL JOB FUNCTIONS 

• Govern the Stability Program on behalf 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

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.