GMP Manufacturing Specialist — Documentation & Quality

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 60,000 - 90,000; Full time

Job summary

Iovance Biotherapeutics, Inc. is seeking a knowledgeable professional for its manufacturing operations, focusing on aseptic processing within a GMP environment. The role supports documentation and compliance activities across batch records, CAPAs, and deviations.

The ideal candidate has a bachelor’s degree in a related field and at least 2 years of GMP manufacturing experience, with strong communication and teamwork skills for a fast-paced, cleanroom setting.

Qualifications

• Bachelor’s degree in biology, biochemistry, bioengineering, or related field.
• At least 2 years of experience in biopharmaceutical GMP manufacturing operations.
• Experience with aseptic processing in cleanroom environments.
• Strong written and verbal communication skills.
• Ability to work in a fast-paced manufacturing environment and in a team.
• Familiarity with 21 CFR Part 11 and GxP practices.

Responsibilities

• Draft and revise SOPs, Batch Records, Deviations, CAPAs.
• Lead investigations and root cause analyses for deviations.
• Own and manage change controls for manufacturing areas and equipment.
• Participate in technology transfer and document sharing.
• Coordinate front-end document requests with supporting departments.
• Ensure Deviations and CAPAs are addressed promptly and Batch Records revisions are approved.
• Adhere to GMP, GDP, and SOPs; complete data recording per regulatory requirements.
• Attend weekly management meetings and support project initiation.
• Troubleshoot and prioritize workload on the floor to solve problems.
• Maintain data integrity and protocol compliance.

Skills

Aseptic processing

GMP manufacturing

Cleanroom environment

Documentation

Root cause analysis

Team collaboration

Microsoft Office

Education

Bachelor’s degree in biology/biochemistry/bioengineering or related field

Tools

LIMS/MES

Job description

Iovance Biotherapeutics, Inc. is seeking a knowledgeable professional for its manufacturing operations, focusing on aseptic processing within a GMP environment. The role supports documentation and compliance activities across batch records, CAPAs, and deviations.

The ideal candidate has a bachelor’s degree in a related field and at least 2 years of GMP manufacturing experience, with strong communication and teamwork skills for a fast-paced, cleanroom setting.