Quality Control Analyst II - Microbiology [Contract to Hire]

Iovance Biotherapeutics - Philadelphia, PA

Full-time - Mid Level

Philadelphia, PA

1-10 employees

Chemical Manufacturing

About the position

The Quality Control Analyst II - Microbiology will support quality control testing operations at Iovance's Cell Therapy Center, focusing on microbial testing for drug products. This role involves performing various microbiological assays, ensuring compliance with GMP regulations, and supporting product stability programs. The position requires working across different shifts, including potential overtime, weekends, and holidays.

Responsibilities

• Perform daily GMP Quality Control laboratory testing activities with minimal errors.
• Conduct environmental monitoring of cleanroom areas as scheduled.
• Analyze data and report results of microbiology assays to support product lot release.
• Support technical problem-solving for GMP Quality Control issues.
• Execute stability testing and analyze stability data for product stability programs.
• Generate and revise documentation such as SOPs, protocols, and reports.
• Act as a subject matter expert on specific assays and train new laboratory personnel.
• Ensure compliance with safety SOPs and laboratory procedures.

Requirements

• Bachelor's degree in a relevant discipline (biological sciences or equivalent).
• 3-8 years of experience in the pharmaceutical industry within a Quality Control role.
• Detail-oriented with strong technical skills.
• Ability to manage multiple priorities with aggressive timelines.
• Demonstrated sense of urgency and accountability.
• Previous experience with GDP, GLP, GMP.

Nice-to-haves

• Advanced degree (MSc. preferred).
• Experience with cell therapy products.

Benefits

• Competitive salary range of $73.1K - $92.6K per year.
• Opportunity for contract to hire position.