Microbiology Laboratory Manager
Position Overview
ATL is seeking a dynamic Microbiology Manager to join our team of dedicated professionals focused on client service and quality. The ideal candidate will be motivated, energetic, forward-thinking, and possess outstanding leadership development and/or technical skills, organizational awareness, and a commitment to excellence.
Major Responsibilities:
- Efficient and effective planning of workflow in the Microbiology Laboratory
- Ability to delegate tasks and workload in a manner that ensures the timely completion of testing and scheduled laboratory tasks
- Laboratory tasks include but are not limited to:
- Routine laboratory maintenance, SOPs reviews, re-training etc.
- Effectively delegate non-scheduled events such as projects
- Proactively evaluate laboratory workflow for continuous improvement opportunities to enhance efficiency and effectiveness of the services we provide to our clients
- Laboratory tasks include but are not limited to:
- Maintain and ensure compliance cGMP systems
- Ensure compliance with applicable SOPs, review, and revision of SOP’s, test methods etc.
- Creation and/or review of protocols, technical reports, data collection sheets, logbooks, and raw data
- Ensure employees are properly trained in labs systems, methods, SOPs etc.
- Proactively evaluate the laboratory’s quality systems for gaps in current compliance standards and/or industry trends for compliance. If gaps are identified, will mitigate these gaps
- Capable of hosting tours of the micro-laboratory by regulatory or client auditors and serve as a Subject Matter Expert (SME) if called upon
- Participation in client interactions and support client requested initiatives
- May include internal microbiological studies and special projects
- Write protocols, interpret data, and/or write technical reports
- Work with client services to build relationships with existing clients, expand relationships with existing clients, and strive to provide opportunities for the client to have an exceptional experience
- Proactively develop staff
- Coach and provide feedback on job performance
- Annual performance evaluations and identifying development opportunities
- Assist with training new hires
- Cross-train existing staff
- Facilitate compliance with annual re-training
- Identify and develop strong performers in the microbiology laboratory to establish ATL’s next generation of management and/or technical leaders
- Responsible for initiating and/or conducting investigations for OOS, deviations, CAPA’s, change controls according to the quality system
- Identify trends related to “laboratory as cause” OOS investigations and deviations, and conduct CAPA to eliminate these trends
- Utilization of technical abilities and problem-solving (investigational) skills to solve internal laboratory problems, resolve customer issues, and to investigate OOS results
- Develop staff’s technical and/or problem-solving skills (investigational) skills to drive for root cause
- Maintain a safe work environment in a GMP-FDA regulated environment according to OSHA Laboratory Standard
- Comply with the Chemical Hygiene Plan and accident reporting
- Establish systems for ensuring a high-level lab hygiene
- Manage the business of the Microbiology Laboratory
- Maintain and/or establish metrics for the Microbiology Laboratory to understand and manage the efficiency and effectiveness of the group and/or individuals
- Utilize these metrics to mitigate risks, improve performance, and/or to celebrate group accomplishments
- Awareness of business laboratory’s performance against annual fiscal/budgetary targets
- Manage resources to exceed annual fiscal/budgetary targets
- Keep abreast of new technologies in microbiology and/or compliance trends related to the microbiology lab
- Propose and potentially lead efforts to implement new technologies and/or mitigates gaps in the lab’s cGMP systems
- Foster a culture of “continuous improvement” in the laboratory and throughout the organization
- Ability to react to change productively and effectively lead and /or manage change
Requirements:
- Experience working in a regulated environment
- Experience managing people
- Practical experience in lab operations (optimization & development)
- Experience troubleshooting & problem-solving
- Microbiology
- Practical experience with the following USP methodologies – <51>, <61>, and <62>
- Proficient with USP methods and criteria
- Demonstrated equipment and method validation experience
- Practice in the cosmetic and medical devices industries
- Biotech experience
- Minimum of 5 + years of relevant experience
- Minimum of 2 + years of management experience
- 4 year Bachelor's Degree in relevant field
Company Overview
At ATL, we don’t just do the science, we have the opportunity to transform organizations. We need people who want to grow with us and contribute directly to our clients’ success. As scientific sourcing experts, the largest and most respected companies in the world ask us to create innovative solutions to big problems. We have more input and influence, so we can have a significant impact on brand-name products and visible projects. And you can play a bigger role.
Interested and qualified candidates, please apply with a resume and salary requirements.
ATL offers a comprehensive benefits package including: Medical, Dental, Vision, Life Insurance, Short Term Disability, Long Term Disability, Pet Insurance, a 401(k) Retirement Plan with company contribution, Paid Time Off, and an Associate Assistance Plan. In addition, we offer a competitive salary and the advantage of a professional environment that supports your development and recognizes your achievements.
ATL is an Equal Opportunity Employer (EOE) and strongly supports diversity in the workplace.
