Bioprocess Engineer (MSAT)

JR United Kingdom; Grangemouth; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Bioprocess Engineer (MSAT) to join their expanding facility in Grangemouth. This role involves leading the technology transfer of Antibody Drug Conjugate (ADC) processes while ensuring compliance with Good Manufacturing Practices (GMP). You will be responsible for preparing GMP batch records, managing manufacturing documentation, and evaluating materials for process suitability. This position offers an exciting opportunity to contribute to innovative drug development in a collaborative environment, making a significant impact on the pharmaceutical industry. If you have a passion for bioprocessing and a strong background in GMP compliance, this role is perfect for you.

Qualifications

• Proven experience in GMP Biologics manufacturing and process development.
• Strong planning skills to influence stakeholders in technical projects.

Responsibilities

• Prepare GMP batch records and review manufacturing documentation.
• Lead technology transfer from development to manufacturing scale.
• Perform risk assessments and manage process introduction.

Skills

GMP Biologics manufacturing

Process development

Planning and organization

Process scale-up

Communication skills

Process improvement

Job description

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

We are expanding with our new 45 million pound facility in Grangemouth and have a need for a Bioprocess Engineer (MSAT) to support our projects.

Responsible for the technology transfer of both new and repeat Antibody Drug Conjugate (ADC) processes from Process Development to Manufacturing in compliance with Good Manufacturing Practices (GMP), including generation of all required process and technical documentation. Work compliantly within Piramal Quality Management System (QMS) to ensure processes meet company and regulatory requirements. Lead and manage implementation of improvement actions identified through CAPA actions and end of campaign lessons learned.

Key Roles/Responsibilities:

1. Prepare GMP batch records for use in GMP manufacturing processes.
2. Review, approve, and issue manufacturing documentation.
3. Determine scale-up criteria from development to manufacturing scale.
4. Generate process mass balances and flow diagrams.
5. Identify, design and define large scale manufacturing equipment.
6. Define materials for use in a GMP manufacturing environment.
7. Generate quality documentation for raw materials and equipment.
8. Work within the Piramal quality system to initiate, manage and evaluate requests for change.
9. Perform investigations, close CAPA’s and deviations.
10. Project manage all aspects of the introduction of processes to manufacturing.
11. Perform risk assessments in alignment with ICH 9Q.
12. Evaluate process materials for suitability for use in manufacturing.

Minimum Requirements:

• Proven GMP Biologics manufacturing or process development experience.
• Strong planning and organization skills to influence and gain support from key stakeholders that collaborate to deliver technical transfer projects.
• Process scale-up, transfer and manufacturing support.
• A proven track record to meet project deadlines.
• Ability to communicate with vast cross sections of people at all levels of the business.
• Evaluation of materials for process suitability.
• Writing GMP batch records.
• Commercialisation of biological medicines and process validation.
• Experience of process improvement and process mapping.
• Definition, sourcing, and validation of large-scale process equipment.