Bioassay Team Manager

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Job Description

Key Roles and Responsibilities:-

Departmental Management:

• Manage the training, development and administration of team members.
• Establish priorities for self and team. Long term objectives are aligned with the Analytical Development and Quality Control Departments and client commitments.
• Ensure efficient use of time to complete objectives.
• Lead projects and teams to deliver method development, qualification and validation studies, QC release and stability data for biological assays and ensuring the data and reports are suitable for regulatory filings.
• Support for forward planning and management of resources (staff, equipment and infrastructure).
• Implementation and tracking of Bio-assay team performance and quality measures and targets.
• Ensure good communication with QC and AD management to ensure priorities are aligned, maintain focus on site requirements for prioritisation of workload.
• Maintain laboratory areas and equipment, ensuring procedures are complied with to meet client, regulatory GMP and safety requirements.
• Identify and introduce new equipment as required and in line with site procedures.
• Provide training and troubleshooting support where required.
• Engage in and lead specified compliance and improvement projects, as required.
• Ensure economic use of labour, materials, energy and services, proposing and implementing measures for resource optimisation, cost reduction and waste minimisation to meet the department and site targets.
• Lead the management of the laboratory ensuring effective systems are in place to meet client, regulatory GMP and safety requirements.
• Identify opportunities for improved methods of working to enhance efficiency, cost control and safety/GMP performance.
• Risk Assessment of new products to ensure personnel safety compliance with company requirements for Health and Safety and development expectations.

Project Scheduling and Delivery:

• Responsible for planning workload to ensure that assigned projects and deliverables are fully completed on time.
• As required, lead development, technical transfer, qualification, validation and technical support for bio-analytical methods.
• Plan and carry out work to ensure effective project progression in line with customer requirements.
• Liaise with client technical and quality groups and provide advice and direction on biological assay requirements.
• Act as in-house biological assay expert, taking decisions on scheduling of workload in conjunction with other technical and quality staff.
• Act as client point of contact for projects, providing professional and timely updates/information.

Quality

• Ensure Bioassay laboratories are compliant with GMP, well organised, and in a state of continuous inspection readiness.
• Issue, lead and ensure timely close out of any department associated quality system records and reports, including deviation investigations, CAPA, Change Control, Audit Actions and Periodic Reviews,
• Uphold cGMP and ESH standards, continually seek opportunities to improve and enhance standards, and encourage other staff to do likewise.
• Lead efforts to ensure best cGMP work-practices and techniques to ensure testing and reporting in accordance within target milestones, reporting and support release of bulk drug substance, final products and stability products.

Qualifications

Key Competencies:-

• Technical Expertise - expertise in bio-analytical techniques
• Teamwork -As a team member, the ability and desire to work cooperatively with others on a team
• Communication - The ability to ensure that information is passed on to others who should be kept informed.
• Organisation - The ability to efficiently plan and prioritise across a range of timeframes, making efficient use of time.
• Customer Awareness - The ability to demonstrate concern for satisfying one's external and/or internal customers.
• Attention to Detail - Ensuring that one's own and others' work and information are complete and accurate
• Problem Solving - The ability to accurately assess a situation and derive a positive outcome.