Description
BUSINESS: Piramal Pharma Solutions
DEPARTMENT: Manufacturing
LOCATION: Grangemouth
Job Overview:-
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.
Reporting Structure:-
Reports to Deputy Head of MSAT
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:
* Commercialization of biological medicines and process validation
* Experience of process improvement and process mapping
* Definition, sourcing, and validation of large-scale process equipment