Bioprocess MSAT Engineer – ADC Tech Transfer & GMP

Piramal Pharma Solutions; United Kingdom; On-site; GBP 40,000 - GBP 60,000; Full time

Job summary

A leading global CDMO in the United Kingdom is seeking a Bioprocess Engineer (MSAT) to support its expanding project portfolio. This role involves technology transfer of Antibody Drug Conjugate (ADC) processes, ensuring full GMP compliance and generating necessary documentation. The ideal candidate will have strong project management and communication skills, with experience in GMP biologics manufacturing. You'll manage process introduction to manufacturing and evaluate change controls within the company's quality management system.

Qualifications

• Proven experience in GMP biologics manufacturing or process development.
• Experience in process scale-up, technology transfer, and manufacturing support.
• Proven track record of meeting project deadlines.

Responsibilities

• Prepare GMP batch records for use in manufacturing operations.
• Review, approve, and issue GMP manufacturing documentation.
• Produce process mass balances and flow diagrams.
• Project manage all aspects of process introduction into manufacturing.
• Conduct investigations and close CAPAs and deviations.

Skills

GMP biologics manufacturing experience

Process development

Strong planning and organizational skills

Project management

Strong communication skills

Job description

A leading global CDMO in the United Kingdom is seeking a Bioprocess Engineer (MSAT) to support its expanding project portfolio. This role involves technology transfer of Antibody Drug Conjugate (ADC) processes, ensuring full GMP compliance and generating necessary documentation. The ideal candidate will have strong project management and communication skills, with experience in GMP biologics manufacturing. You'll manage process introduction to manufacturing and evaluate change controls within the company's quality management system.