Manager Genezen Jobs (NOW HIRING)

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 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