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The main functions of this role are
* To manage the establishment, maintenance and reporting of MedImmune Vaccines stability programs for drug product, drug substance and associated raw materials and buffers.
* To manage the distribution of samples and Materials sent to Outside Testing Laboratories, Internal Laboratories and other MedImmune sites and reporting of results.
* To ensure completion of conditional/final release certificates of analysis, lot release protocols and annual product reviews.
Major Duties and Responsibilities:
* To ensure the team operate and comply with the required standards with respect to documentation, good housekeeping, cGMP, health and safety, timekeeping, budgeting, regulatory legislative requirements and in accordance with the rules and requirements of the GMP Compliance Rule book, the Code of Conduct, quality manual and any other company policies and procedures
* Take ownership of, and be responsible for, all actions undertaken as part of the role, to ensure commitments to the organization and colleagues are always met.
* Ensure Operational Excellence is integrated into the team's responsibilities. This should include adopting a philosophy of continuous improvement and a "Right First Time from Me" attitude to all operations.
* Ensure that the data required for product release is available to allow conditional/final release certificates of analysis and lot release protocols and annual product reviews to be prepared and distributed within agreed timelines.
* Provide an interface /communication between Supply Chain Operations, internal & external customers and the UK-1 Laboratories to ensure that internal/external testing timelines/ adherence are communicated to the right level and in the appropriate timelines
* Ensure that samples are delivered, stored and distributed internally and to external testing facilities in compliance with GMP and local procedures within agreed time lines.
* Develop strategies and plans for the Stability /Sample management group with a 0-6 month planning horizon in collaboration with other departments across site to develop the team to ensure that the site meets the future business goals
* The promotion of good company relations with external parties to ensure the provision of a quality and efficient service to internal and external customers
* Leadership in support of Laboratory management developing a motivated, informed and efficient workforce through development, training, mentoring and other initiatives
* To lead a team of QC Technicians and Analysts to ensure all QC activities is performed and completed to support commercial operations and schedule adherence, utilizing effective resource planning and management
* The jobholder should ideally have a minimum of a degree or equivalent in a biological discipline as appropriate to laboratory specialty.
* The jobholder should have extensive experience in laboratory working and supervision, preferably related to pharmaceutical or biotechnology operations
The setting of performance objectives, the undertaking of performance appraisals and reviews, the identification of areas for staff development and the undertaking of disciplinary action and grievances
* To lead daily meetings and escalate any issues to the appropriate team leader or manager.
* To present the monthly team brief, including preparation and delivery of the local brief.
* Responsible for developing and executing a team development plan in line with the Quality Control development plan.
* Responsible for developing and communicating team performance indicators including target setting and improvement plans.
* Manage and track the progress of deviations to ensure that they are closed within the required timelines and to agreed standards
* Maintain budgetary awareness; ensure that all activities are performed within budget constraints and to reduce costs where appropriate.
* Preparation, Review and Approval of laboratory protocols and reports.
* Preparation and review regulatory submissions, provision of subject matter expertise in regulatory Audits
* Provide new and improved methods of working or equipment/ systems to drive continual improvement utilizing Operational Excellence (OE) Right First Time (RFT) and Quality at Source (QAS) tools
* Liaise with maintenance staff and suppliers to ensure laboratory equipment and services are maintained to a high standard and in good working order.
* Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
* Perform internal audits and external audits on contract test laboratories or suppliers as required.
* Ensure the compliance of all laboratory procedures and personnel with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.
* Contribute to problem-solving initiatives internally, cross site and with external testing facilities