Piramal Pharma Solutions
Job Description
Piramal Pharma Solutions is a leading global CDMO of advanced drug development and manufacturing solutions to the pharmaceutical industry
We are looking for an Experienced NPI Manager to join our expanding team and support with our 40 million facility
Responsible for siting both new processes and repeat campaigns to manufacturing. Generate all required process and technical documentation for implementation of processes to manufacturing. Work compliantly within Piramal Quality system to ensure processes meet company requirements. Lead and manage implementation of improvement actions highlighted through CAPA actions and SFTI initiatives. You will have a strong team of NPI bioprocess engineers to which you will manage and support.
Key Roles/Responsibilities:
- Prepare GMP batch records for use in 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
- Excellent troubleshooting skills
- Strong customer focus
- Strong organisational skills
- Thorough approach and high attention to detail
- Excellent communication skills; ability to articulate technical and business concepts, ideas, opinions and conclusions orally and in writing
Essential Experience
- Proven GMP Biologics manufacturing or process development experience and technical knowledge and ability
- Strong leadership and organization skills to influence and gain support from key departmental areas that collaborate to deliver technical transfer projects
- Project management of technical teams and projects
- Process scale up, transfer and manufacturing support
- A proven ability to meet project costs and deadlines is essential
- Ability to communicate with vast cross sections of people is essential
- 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
- People management
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