GMP Manufacturing Manager - downstream

CW Recruitment Specialist
West Lothian
£Exc + bens
13 Oct 2016
20 Oct 2016
Contract Type
CWRS Invites applications on behalf of its client, a leading organisation within the biotechnology sector, where an excellent opportunity now exists for a permanent Manufacturing Manager of Downstream Processing to join their team on site in West Lothian, near Edinburgh. Job Purpose: Utilisation of team resources and skills to ensure robust delivery of Upstream / Downstream manufacture and associated processes involved in production, through management of team and activities according to defined procedures and best cGMP work practices, quality standards and metrics.To provide technical support to process, regulatory and business requirements Key duties include: · Ensure delivery and supervision of production task execution to cGMP standards, and ensure team compliance to the same consistent standard. To ensure consistent outputs and product within specification. · Routine delivery of forward-view manufacturing weekly plans. Co-ordination of preparation activities and resourcing of tasks to ensure timely delivery. · Own and manage delivery of documentation for review and comment closure through to completion for process and support activities (including PPRs, Validations, Qualifications, Reports) in a timely manner as required for the established systems · Timely escalation of deviations / problems with materials, facilities, process or procedures through Line Management or other suitable channels · Accountability for the housekeeping standards of the defined areas, equipment and materials of ownership. Ensure team compliance with HSE requirements in conducting all activities in a safe manner · Support manufacturing operations with technical input to validations, training modules, regulatory enquiries and audits · Ensure their team and their own training is current and maintained to provide competence and compliance · Development of team capabilities to meet the business needs and to aid a continued enthusiastic, supportive and collaborative environment · Identify and escalate ideas for continuous improvement, and drive through to implementation using Change Management techniques. Development of Best Practice techniques and technical excellence within the team Reporting to the Head of Manufacturing Operations this post has 10 direct reports including manufacturing scientists and assistants. The role is a shift role between 6am and 6pm Monday to Friday and including working a Sunday on a rotational basis. The successful candidate will have/be: · Min. HNC in relevant field or equivalent experience · Cell culture experience and/or viral propagation · Experience working in a GMP manufacturing environment · Experience working in biologics or biopharmaceuticals · Proven line manager experience with ability to motivate a team · Previous audit experience as SME or advisor · Strong team player with ability to work cross-functionally and encourage functional interactions throughout the team If you feel you meet the above requirements, we would like to hear from you without delay. A highly competitive remuneration package is off in return. This job was originally posted as