Key Roles/Responsibilities:
* Prepare GMP batch records for use in GMP manufacturing processes.
* Review, approve, and issue manufacturing documentation.
* Determine scale-up criteria from development to manufacturing scale.
* Generate process mass balances and flow diagrams.
* Identify, design and define large scale manufacturing equipment.
* Define materials for use in a GMP manufacturing environment.
* Generate quality documentation for raw materials and equipment.
* Work within the Piramal quality system to initiate, manage and evaluate requests for change.
* Perform investigations, close CAPA's and deviations.
* Project manage all aspects of the introduction of processes to manufacturing.
* Perform risk assessments in alignment with ICH 9Q.
* Evaluate process materials for suitability for use in manufacturing.
Competencies:
* Good time organisation skills
* Strong team working ability
* Good communication skills
* High level of attention to detail
* Good problem solving skills
* Good decision making skills
Qualifications
Essential Qualifications
Preferably BSc (Hons) in Science or Engineering discipline (or equivalent) required.
Essential Experience
* 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.
* Strong project management skills.
* 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.
Desirable Experience:
* Commercialisation of biological medicines and process validation.
* Experience of process improvement and process mapping.
* Definition, sourcing, and validation of large-scale process equipment.
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