Job Description

Business: Pharma Solutions

Department: Analytical Development

Location: Grangemouth

Reporting Structure:

Reports to Bioassay Team Manager

Scientist responsible for the method development, qualification/validation, technical transfer, stability and QC release testing within the Bio-Assay team.

Key Responsibilities

• Establish own day to day priorities. General guidance and long-term objectives are provided by the Bio-Assay Senior team.
• Provide project support for routine Bio-Assay QC and stability testing, method development, technical transfer and validation activities according to defined SOPs and protocols and in compliance with best cGMP working practices and techniques.
• Check and review data in compliance with Data Integrity requirements.
• Maintain laboratory areas, ensuring procedures are complied with to meet client, regulatory, GMP and safety requirements. Be accountable for the bioassay laboratories being clean, tidy and well-organised and in a state of continuous inspection readiness.
• Execute calibration of equipment and instruments, informing relevant personnel in a timely manner of any failure of calibration. Carry out general maintenance and housekeeping of equipment.
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Provide training and troubleshooting support to Development and Quality Control groups as required.
• Engage in specified compliance and improvement projects.
• Workload planning with other staff to ensure required timelines are met.
• Provide cover for other Bio-Assay Scientists as required.
• Have ownership and ensure timely close out of deviations, investigations, change controls and commitment tracking.
• Immediately escalate and report and deviations to materials, facilities, processes or procedures to Bio-assay and QC management.
• Assist Bio-Assay team in the implementation of measures and targets:
• Ensure economic use of labour, materials, energy and services, proposing and implementing measures for cost reduction and waste minimisation to meet the department and site targets.
• Support and provide training of new members of staff to the company/department.
• Apply best cGMP work-practices and techniques to manage the testing and release bulk drug substance, final products and stability products within specification and in accordance with Data Integrity requirements, Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data
• Uphold cGMP principles and ESH standards in his/her area of responsibility, continually seek opportunities to improve and enhance standards, and encourage other staff to do likewise.
• Provide Bio-assay project support, have involvement in decisions on scheduling of release, stability, development, technical transfer and validation in conjunction with other technical staff.
• Identify opportunities for improved methods of working to enhance efficiency, cost control and safety/GMP performance.
• Assist in the introduction of new equipment by supporting IQ/OQ/PQ and comparison studies where applicable
• Be the system owners of Bio-Assay equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Bio-Assay department.
• Write and update of SOPs, instructions and protocols and other documentation
• Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.

1.Release, Stability, Development, technical transfer and validation

2.Troubleshooting

3.Deviation, change control and commitment tracking close out

Key Competencies:-

• Experience /expertise in cell based assay techniques
• Ability to follow instructions accurately
• Attention to detail
• Reliability and effective communication
  

Essential Qualifications:-

BSc in a relevant Scientific discipline or equivalent

Essential Experience

A minimum of 2 years analytical experience, with a sound working knowledge of GMP & SHE standards and safety matters together with highly developed interpersonal and team building skills.