Job Title – Microbiology Manager
Location – Deeside
Contract Length – Perm
Pay Rate – 60k Key Responsibilities
To act as a technical expert on behalf of the organisation by providing advice, guidance, and expertise on microbiological issues.
Actively manage the microbiology laboratory team, including effective engagement, communication, recruitment, and employee development.
Responsible for managing the microbiology testing programme. Ensure all microbiological testing, methods and validation exercises reflect applicable regulations/guidelines and meet industry best practice.
Accountable for meeting targeted KPI’s and monitoring team performance; maintain and update all assigned systems and databases. Provides regular management reports as required.
Responsible for microbiology test method validation and equipment validation requirements in accordance with procedures.
To manage and ensure appropriate allocation of laboratory resources and drive on-time completion of team activities.
Accountable for software validation activities for the deployment of microbiology laboratory equipment software packages.
Accountable for Microbiology Laboratory safety, including the timely preparation and approval of all required laboratory safety deliverables.
Lead/manage continuous improvement initiatives within microbiology systems.
To lead/manage microbiology laboratory related non-conformances, CAPA’s, planned deviations, change controls, OOS’s as required, ensuring corrective actions are fully implemented to address root causes etc.
Perform other activities as and when required to support laboratory operations.
Skills & Experience
Preferably 7+ years’ experience working in the Medical Device / Pharmaceutical Industry within a R&D/product development role.
Experience with FDA 510k submissions and test methods for microbiological claims.
Strong background in microbiology, significant experience, track record and knowledge within Microbiology or a Laboratory Management environment.
A drive for excellence and high attention to detail.
Ability to lead, motivate, develop, and influence a team.
Competent to provide technical support and advice to other functions and franchises; serves on various teams as a functional leader.
Strategic thinking capabilities evidenced by successful delivery of projects in a previous laboratory role.
Strong organisational skills and the ability to manage business complexity and multiple priorities at one time.
Ability to network internally and externally and stay engaged via industry best practices and standards.
Good interpersonal skills and ability to form effective working relationships
Qualifications/Education:
Degree level in a biological science discipline, preferably in microbiology.
Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2015, FDA 21 CFR part 820) and GMP Guidelines and Regulations.
Possess a flair for problem solving, identifying inefficiencies and implementing solutions.
Microsoft Office skills are essential.
Working knowledge of statistics and software packages are preferable.