Overview
Stability Manager, Quality Control Jobs in Lexington, USA at Genezen
Genezen is a CDMO dedicated to delivering GMP viral vectors, cell transduction, and analytical services for gene and cell therapy clinical trials.
JOB SUMMARY
The QC Senior/Principal Scientist for Analytical Method Validation leads the transfer and validation of next‑generation analytical procedures for the testing of viral vectors, cell banks, and gene therapy products in compliance with company policies, regulatory guidelines, and client requirements.
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
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
EDUCATION
- Master’s Degree in a 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 GMPs 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 GMP environment
- Subject matter expert in Good Documentation Practices (GDP)
- Excellent project management tools (MS Project, Smart Sheets)
- 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 must meet the following physical demands:
- 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
- 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
- Frequently lift and/or move up to 25 pounds; occasionally lift and/or move up to 50 pounds
- Frequently utilize close vision and the ability to adjust focus
- Frequently required to communicate by talking, hearing, using telephone and e‑mail
BENEFITS
- Paid vacation days, amount based on tenure
- 401(k) plan with company match up to 6% of salary, vested immediately
- Choice of several healthcare plans
- FSA and HSA programs
- Employer‑paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident 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.
EEO STATEMENT
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.
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Title: Stability Manager, Quality Control
Company: Genezen
Location: Lexington, USA
Category:
