Microbiology Supervisor
Microbiology Supervisor
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Microbiology Supervisor is responsible for the management and operation of the Microbiology Laboratory as well as for the testing and approval of raw materials and finished products, managing investigations and deviations, and communicating results to management. They will ensure compliance with company and compendial specifications, quality standards, and global regulations in support of the Hard Capsule (HC), Ingredients, Global Stability, Product Development, and Dosage Forms Solution (DFS) businesses. In addition, they will provide leadership, support and supervision to microbiology colleagues.
Key responsibilities:
- Leads all activities associated with the daily operation of the Microbiology Laboratory; and on occasion, performs routine testing of raw materials and finished products.
- Leads Microbiology activities associated with novel dosage forms produced in Innovation / Product Development group, including samples from the Lonza Ingredients portfolio, Global Stability and DFS stability studies.
- Reviews and maintains documentation and records for accuracy and compliance.
- Prepare for and actively participate in internal and external Quality audits and incident investigations and reporting
- Provide direction and technical expertise to Microbiology laboratory personnel and to the plant.
- Utilize common problem-solving tools and methodologies in processes and procedures for root cause analysis and resolution of Micro related issues
- Model a thorough understanding of what drives costs / profitability within the department, while operating within budget, material utilization, and goals.
- Communicates with all levels of management regarding material release, product requirements, and ensures that materials meet regulatory requirements.
- Conducts professional dialog with internal and external customers, including complaint handling.
- Ensures timely closure of customer complaints.
- Conducts and leads meetings and communications effectively.
- Writes and updates Standard Operating Instructions, Policies, Protocols and Specifications.
- Reviews all SOI(s) and WI(s) for the Microbiology Laboratory.
- Assists the lab with any microbiology issue such as compliance issues, questions and concerns. Also provides guidance to appropriate areas as it relates to Microbiology.
- Prepares facility & laboratory monthly Microbiology trending reports.
- Initiate & execute corrective actions based on trending results.
- Manages KPI performance, goals and objectives.
- Issues and tracks necessary deviations, change control, MER (Material Evaluation Reports), and CAPA(s) related microbiology department.
- Reviews investigations dealing with finished product and raw materials out-of-specification results.
- Responsible for the evaluation, mentoring, coaching and development of laboratory colleagues.
- Reviews and approves microbiology investigations.
- Review laboratory documentation which includes CofA, logbooks/notebooks, media QC sheets, environmental monitoring, etc.
- Supports and coordinates validation, special projects and other assignments related to microbiology department
- Manages microbiology laboratory budget
- Must be able to work 40 hours a week, which may include weekends, holidays, etc.
- Must be able to work additional hours/days as business needs dictate
- Attendance in the plant site is considered an essential function.
Key requirements:
- Bachelor’s degree or higher in Microbiology required.
- Experience in a GMP manufacturing environment, ovens, incubators, autoclave, dishwasher, laminar-flow hood, and Vitek Identification System is preferred.
- Advanced experience in a Laboratory required.
- Knowledge of applicable regulatory standards and requirements is preferred.
- Excellent communication skills, both verbal and written.
- Strong proficiency with word processing and spreadsheet software is required.
- Ability to manage teams and lead colleagues in the completion of goals.
- Must be able to interact with colleagues at all levels of the business.
- Must be highly organized, detail-oriented, and able to manage multiple projects.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.