Bioprocess Engineer (MSAT)

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

Piramal Pharma Solutions is a leading global CDMO providing advanced drug development and manufacturing solutions to the pharmaceutical industry.

We are continuing our growth with the opening of our new £45 million facility in Grangemouth, and we are seeking a Bioprocess Engineer (MSAT) to support our expanding project portfolio.

In this role, you will be responsible for the technology transfer of both new and existing Antibody Drug Conjugate (ADC) processes from Process Development to Manufacturing, ensuring full compliance with Good Manufacturing Practices (GMP). You will generate all required technical and process documentation and work within the Piramal Quality Management System (QMS) to ensure adherence to company and regulatory standards. You will also lead and manage the implementation of improvements identified through CAPA actions and end-of-campaign reviews.

Key Responsibilities

• Prepare GMP batch records for use in manufacturing operations.
• Review, approve, and issue GMP manufacturing documentation.
• Define scale-up criteria from development to manufacturing scale.
• Produce process mass balances and flow diagrams.
• Identify, design, and specify large-scale manufacturing equipment.
• Define materials required for GMP manufacturing.
• Generate quality documentation for raw materials and equipment.
• Initiate, manage, and evaluate change controls within the Piramal QMS.
• Conduct investigations and close CAPAs and deviations.
• Project manage all aspects of process introduction into manufacturing.
• Perform risk assessments in alignment with ICH Q9 guidelines.
• Assess process materials for suitability in manufacturing.
• Proven experience in GMP biologics manufacturing or process development.
• Strong planning and organisational skills, with the ability to influence and engage stakeholders involved in technology transfer.
• Demonstrated project management capability.
• Experience in process scale-up, technology transfer, and manufacturing support.
• Proven track record of meeting project deadlines.
• Strong communication skills, with the ability to work effectively across all levels of the organisation.
• Experience evaluating materials for process suitability.
• Experience writing GMP batch records.
• Experience with commercialisation of biological medicines and process validation.
• Process improvement and process mapping experience.
• Defining, sourcing, and validating large-scale process equipment.