GMP Biologics Manufacturing Specialist

3 weeks ago


Falkirk, Falkirk, United Kingdom Piramal Group Full time
Key Responsibilities:

We are seeking a highly skilled GMP Biologics Manufacturing Specialist to join our team at the Piramal Group. In this role, you will be responsible for preparing GMP batch records, reviewing and approving manufacturing documentation, and determining scale-up criteria from development to manufacturing scale.

You will also be responsible for generating process mass balances and flow diagrams, identifying and designing large-scale manufacturing equipment, and defining materials for use in a GMP manufacturing environment. Additionally, you will generate quality documentation for raw materials and equipment, work within the Piramal quality system to initiate, manage, and evaluate requests for change, and perform investigations, close CAPA's, and deviations.

As a Large Scale Manufacturing Expert, you will project manage all aspects of the introduction of processes to manufacturing and perform risk assessments in alignment with ICH 9Q. Your strong planning and organization skills will enable you to influence and gain support from key stakeholders that collaborate to deliver technical transfer projects.

Essential Qualifications:
  • BSc (Hons) in Science or Engineering discipline (or equivalent)
  • Proven GMP Biologics manufacturing or process development experience
Desirable Experience:
  • Commercialisation of biological medicines and process validation
  • Experience of process improvement and process mapping


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