Stability QC Leader - Gene Therapy CDMO

Genezenlabs; Lexington (MA); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

Paid vacation days

401(k) with company match

Healthcare plans

Paid sick time

Dental & vision care

Job summary

Genezenlabs in Lexington, Massachusetts is seeking a Manager for QC Stability to oversee stability programs through commercial phases. The role involves ensuring regulatory compliance, providing leadership, and collaborating with cross-functional teams to maintain product quality.

The ideal candidate will have over 8 years of relevant experience in the CDMO sector, a Master’s degree in a science-related field, and strong capabilities in problem-solving and communication.

Qualifications

• 8+ years of industry experience in CDMO.
• Experience managing stability programs for cell/gene therapy products.
• Strong understanding of cGMPs and global regulations.

Responsibilities

• Govern the Stability Program on behalf of clients across all programs for DS, DP, and diluents.
• Ensure compliance with Quality Agreements and global regulatory expectations.
• Supervise, mentor, and develop team members.

Skills

Leadership

Cross-functional collaboration

Problem-solving

Regulatory compliance

Communication skills

Education

Master's Degree in science-related field

Tools

MS Word

MS Excel

SmartSheets

MS Project

Job description

Genezenlabs in Lexington, Massachusetts is seeking a Manager for QC Stability to oversee stability programs through commercial phases. The role involves ensuring regulatory compliance, providing leadership, and collaborating with cross-functional teams to maintain product quality.

The ideal candidate will have over 8 years of relevant experience in the CDMO sector, a Master’s degree in a science-related field, and strong capabilities in problem-solving and communication.