As a key player in the development of innovative medical solutions, we are seeking an experienced Microbiology Manager to lead our laboratory team. This challenging role will involve oversight of microbiology laboratory activities and management of the microbiology team.
The successful candidate will have a strong background in microbiology and significant experience within a laboratory management environment. They will be responsible for driving the successful development of new products, maintaining quality, compliance and safety standards, and managing the microbiology testing programme.
Key Responsibilities
1. To provide technical expertise on behalf of the organisation by providing advice, guidance, and expertise on microbiological issues.
2. Manage the microbiology laboratory team, including effective engagement, communication, recruitment, and employee development.
3. Responsible for managing the microbiology testing programme and ensuring all microbiological testing, methods and validation exercises reflect applicable regulations/guidelines and meet industry best practice.
4. Accountable for meeting targeted KPI's and monitoring team performance; maintain and update all assigned systems and databases.
5. Responsible for microbiology test method validation and equipment validation requirements in accordance with established procedures.
6. Manage and ensure appropriate allocation of laboratory resources and drive on-time completion of team activities.
7. Accountable for software validation activities for the deployment of microbiology laboratory equipment software packages.
8. Accountable for Microbiology Laboratory safety, including the timely preparation and approval of all required laboratory safety deliverables.
9. Lead/manage continuous improvement initiatives within microbiology systems.
10. 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.
Skills & Experience
1. Preferably 7+ years' experience working in the Medical Device / Pharmaceutical Industry within a R&D/product development role.
2. Experience with FDA 510k submissions and test methods for microbiological claims.
3. Strong background in microbiology, significant experience, track record and knowledge within Microbiology or a Laboratory Management environment.
4. A drive for excellence and high attention to detail.
5. Ability to lead, motivate, develop, and influence a team.
6. Competent to provide technical support and advice to other functions and franchises; serves on various teams as a functional leader.
7. Strategic thinking capabilities evidenced by successful delivery of projects in a previous laboratory role.
8. Strong organisational skills and the ability to manage business complexity and multiple priorities at one time.
9. Ability to network internally and externally and stay engaged via industry best practices and standards.
10. Good interpersonal skills and ability to form effective working relationships.
Qualifications/Education
1. Degree level in a biological science discipline, preferably in microbiology.
2. 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.
3. Possess a flair for problem solving, identifying inefficiencies and implementing solutions.
4. Microsoft Office skills are essential.
5. Working knowledge of statistics and software packages are preferable.
Team: 5-10 direct reports
Working Conditions:
This is a hybrid working model - you will visit our site 3 times per week to collaborate with functional teams and build strong working relationships.
We offer a competitive remuneration package, excellent career opportunities and a dynamic work environment that promotes innovation and collaboration.
We are committed to developing and supporting our people through ongoing training and development programmes.
This is a challenging and rewarding role that requires a unique blend of technical expertise, leadership skills and business acumen.
We look forward to hearing from you if you are a motivated and ambitious individual who is passionate about delivering high-quality results and making a positive impact.